Craigs have initiated research on Pacific Edge.
They don't feel the love and think another equity raise 2026.
We initiate with Neutral and $0.65/sh price target
We value PEB at $0.65/sh on our base case scenario of a revenue ramp up similar to Genomic Health, 15% market penetration by terminal forecast year (FY42), and long term EBIT margins of c.30% (above mature industry peers). With PEB shares trading in line with valuation, we initiate with a Neutral recommendation. We see upside to our valuation if adoption is faster than forecast or PEB is acquired (though our review of takeovers suggests this is unlikely before PEB achieves 10%+ penetration vs <1% currently
Commercialisation likely to cost more than widely believed
While consensus estimates for PEB's revenue growth appear achievable, our analysis of comparable companies suggests that it is likely to cost more to commercialise Cxbladder than widely believed, with only one comp (Genomic Health) ever turning a profit. We forecast cash breakeven in FY28 (two years later than consensus), with additional equity potentially needed in c.FY26.
Quote from: Shareguy on Jun 29, 2022, 08:51 AMCraigs have initiated research on Pacific Edge.
They don't feel the love.
We initiate with Neutral and $0.65/sh price target
We value PEB at $0.65/sh on our base case scenario of a revenue ramp up similar to Genomic Health, 15% market penetration by terminal forecast year (FY42), and long term EBIT margins of c.30% (above mature industry peers). With PEB shares trading in line with valuation, we initiate with a Neutral recommendation. We see upside to our valuation if adoption is faster than forecast or PEB is acquired (though our review of takeovers suggests this is unlikely before PEB achieves 10%+ penetration vs <1% cur
That's cool. Their valuation is above my DCA hold level.
Forbar .... Market penetration <1%
That <1% must be wrong
Crikey..... the inflection point has been reached.
"Pacific Edge today announces the appointment of David Sosa into the new role of Vice President of Market Access and Reimbursement for Pacific Edge Diagnostics USA (PEDUSA).
Mr Sosa's appointment further strengthens the PEDUSA executive suite as it seeks to accelerate the adoption of its advanced genomic biomarker Cxbladder tests as the standard of care for the suspicion of urothelial cancer in patients presenting with haematuria and in the surveillance for disease recurrence.
Mr Sosa, who joined Pacific Edge on June 27, will play a critical role in ensuring the optimal systems and processes are in place to facilitate insurance coverage, payment, test reimbursement, patient access and seamless engagement with all stakeholders in the healthcare value chain. He will have responsibility for medical policy and contracting efforts with healthcare payors to drive commercial success and operating efficiency as well as play a key role in piloting commercial strategies in the Americas.
Pacific Edge Chief Executive Dr Peter Meintjes, said: "We are delighted to welcome David to Pacific Edge at this inflection point for our growth."
Hmm ... does this look like an inflection point to you?
I guess sure - it might bounce at the MA200 ... but than - it might not.
Oh no, not another Vice President
Bad news
How many bucks this guy getting?
Quote from: BlackPeter on Jul 01, 2022, 11:08 AMHmm ... does this look like an inflection point to you?
I guess sure - it might bounce at the MA200 ... but than - it might not.
I suppose they are talking about the inflection point in terms of market penetration and acceptance, rather than SP. Although the two are usually connected.
I'm still optimistic - just less so than 12 months ago - that PEB could be right in that the technology of CX Bladder could become the industry norm, along perhaps with other bio marking products. The next 12 months will be crucial to start increasing revenue and profits as another cap raise won't be as well received as the last one.
I would be surprised if it bounced off the ma200, but then I am often surprised.
Screenshot 2022-07-01 155946.jpg
Quote from: LoungeLizard on Jul 01, 2022, 03:23 PMQuote from: BlackPeter on Jul 01, 2022, 11:08 AMHmm ... does this look like an inflection point to you?
I guess sure - it might bounce at the MA200 ... but than - it might not.
I suppose they are talking about the inflection point in terms of market penetration and acceptance, rather than SP. Although the two are usually connected.
I'm still optimistic - just less so than 12 months ago - that PEB could be right in that the technology of CX Bladder could become the industry norm, along perhaps with other bio marking products. The next 12 months will be crucial to start increasing revenue and profits as another cap raise won't be as well received as the last one.
I guess it might be educational to review the PEB thread on the other forum. Start August 2005 - and there are even at that stage already references to similar bourse sucess stories. Amazing - these companies are probably around since humans learned to make money by telling others that they might make money if they give their money away.
People have been enthusiastic and optimistic over PEB for nearly two decades. For sure - the big success is just around the nexst corner. Just didn't work out so far (well, there have been some spikes and lots of valleys ...). Is it still the guy who can't tuck in his shirts running them? He certainly made a fortune with the money paid by his investors.
Don't think the fundamentals changed, but you never know with these companies - and who knows - tomorrow is another day.
My wife still tries to win the million dollar price in the lottery by investing $2 every other month or so. Same thing, similar chances of success but cheaper. Hey - and it even might work one day.
Very good BP.😂
Quote from: BlackPeter on Jul 01, 2022, 05:27 PMQuote from: LoungeLizard on Jul 01, 2022, 03:23 PMQuote from: BlackPeter on Jul 01, 2022, 11:08 AMHmm ... does this look like an inflection point to you?
I guess sure - it might bounce at the MA200 ... but than - it might not.
I suppose they are talking about the inflection point in terms of market penetration and acceptance, rather than SP. Although the two are usually connected.
I'm still optimistic - just less so than 12 months ago - that PEB could be right in that the technology of CX Bladder could become the industry norm, along perhaps with other bio marking products. The next 12 months will be crucial to start increasing revenue and profits as another cap raise won't be as well received as the last one.
I guess it might be educational to review the PEB thread on the other forum. Start August 2005 - and there are even at that stage already references to similar bourse sucess stories. Amazing - these companies are probably around since humans learned to make money by telling others that they might make money if they give their money away.
People have been enthusiastic and optimistic over PEB for nearly two decades. For sure - the big success is just around the nexst corner. Just didn't work out so far (well, there have been some spikes and lots of valleys ...). Is it still the guy who can't tuck in his shirts running them? He certainly made a fortune with the money paid by his investors.
Don't think the fundamentals changed, but you never know with these companies - and who knows - tomorrow is another day.
My wife still tries to win the million dollar price in the lottery by investing $2 every other month or so. Same thing, similar chances of success but cheaper. Hey - and it even might work one day.
Yep, I'm well aquainted with the conversation on the other forum - got banned over the shut-down period, so I won't be back ;)
If you bought in 12 months ago($1.50), or even added more during the cap raise ($1.35), you would be feeling pretty sick right now.But if you are a holder, as I am, from not much more than two years ago (15c) even at current levels, you've done all right by sticking with PEB,through good times and bad.
The medical sector is glacial-slow to change practices or even adopt a new but better product using existing technology. 2 decades ago today, Fisher & paykel were $1.68 per share and a decade later they had only gone up to $1.94.Not long after that they hit critical mass and the rest is history. Maybe PEB might do the same? That's the nature of this type of stock - it's crystal ball stuff. PEB are now suffering under a bear market like everyone else, so I'll give them a bit more time to come good. If not, I'll take my profits and move on.
https://www.scoop.co.nz/stories/SC2206/S00046/nz-must-start-recognising-biotech-for-the-future-economy.htm
Quote from: BlackPeter on Jul 01, 2022, 11:08 AMHmm ... does this look like an inflection point to you?
It's not what I think..... the quote is attributed to CEO Dr Peter Meintjes.
The CEO is the one calling the shots and I wish him well. Too early for any judgement IMHO.
Quote from: Left Field on Jul 02, 2022, 12:23 PMQuote from: BlackPeter on Jul 01, 2022, 11:08 AMHmm ... does this look like an inflection point to you?
It's not what I think..... the quote is attributed to CEO Dr Peter Meintjes.
The CEO is the one calling the shots and I wish him well. Too early for any judgement IMHO.
I know that this is what the CEO said.
Worthwhile noting - CEO's are not always right ... and particularly CEO's of this specific company have a long record of creating hopes without delivering the goods. The odds are againts him being right this time :p ;
Re the chart - I didn't ask what you think, but what it looks like to you :) - different things.
Anyway - all good fun as long as you are either out or a short term trader who knows what they are doing ...
How many times have they raised capital with promises that success is just around the corner, anyone know ? (please forgive me I have lost count).
My in box today...... (slowly, slowly)
"Pacific Edge today announces it has reached more than 50% enrolment in its study to demonstrate the clinical utility of its advanced genomic biomarker Cxbladder tests in safely stratifying low-risk patients presenting with blood in urine (hematuria).
The Safe Testing of Risk for Asymptomatic Microhematuria (STRATA) study aims to further demonstrate how Cxbladder can safely risk stratify patients presenting with hematuria into those that may receive a less-intense evaluation for the presence of bladder cancer and those that should continue with a standard evaluation.
The clinical utility evidence generated by the STRATA study is expected to strengthen the case for incorporation of Cxbladder tests into the American Urological Association (AUA) guidelines and to promote more-inclusive language for the recommendation of the test, leading to increased adoption of the test into standard of care.
Cxbladder is a suite of advanced genomic biomarker diagnostic tests that are supported by a significant body of peer-reviewed clinical evidence.
In addition to helping clinicians safely de-intensify or intensify the clinical workup for patients presenting with hematuria, the tests can help resolve diagnostic dilemmas during evaluation (e.g., equivocal cystoscopy and atypical urine cytology) and monitor for the recurrence of urothelial cancer in post-treatment patients, reducing the frequency of cystoscopy required in suitable cases. Globally, more than 2,000 urologists have used Cxbladder tests to detect and monitor urothelial cancers in over 80,000 patients........"
If the future is so bright, why hasn't the new ceo brought any shares himself?
Will we find out that old ceo has been slowly selling his?
Why did the old ceo not stay on the board?
Does the old ceo have to disclose?
Shareguy, the new CEO has a lot of performance related incentives to be working hard. Early days.
As for DD.....my memory is that he stuck around for an orderly transition.... and his deck is well and truly finished.
I'm content to wait till the next performance update and judge on facts - not conspiracy theories.
That said IMHO it's a risky share and not for the faint hearted or short term traders.
13 percent growth, not exactly on fire.
Thoughts?
https://www.nzx.com/announcements/395606
PACIFIC EDGE INVESTOR UPDATE - Q1 FY23 TEST VOLUMES RISE 32% ON Q1 FY22
DUNEDIN, New Zealand -- Cancer diagnostics company Pacific Edge (NZX, ASX:
PEB) today announces continuing strong growth in volumes through its
laboratories of its market-leading genomic biomarker Cxbladder tests.
In the three months to the end of June 2022 Pacific Edge processed 7,055
tests up 13% on the 6,242 tests in the three months to the end of March 2022.
The June 2022 figure also represents a 32% increase on the 5,356 tests
processed in the same quarter of the prior financial year.
Encouraging...... but not exciting....... yet.
Quote from: Shareguy on Jul 20, 2022, 09:13 AM13 percent growth, not exactly on fire.
Thoughts?
https://www.nzx.com/announcements/395606
Well, they never did set the world on fire, didn't they? ... and now they are just continuing with this well entrenched and over more than a decade rehearsed trait.
No doubt they will continue as long as there are shareholders around happy enough to feed them and finance their decks.
C'mon BP, you sound a bit down and out today with your posts. Cheer up
What's not to like about this chart --- CAGR of 54% is pretty amazing
0000peb.JPG
Quote from: winner (n) on Jul 20, 2022, 09:53 AMC'mon BP, you sound a bit down and out today with your posts. Cheer up
What's not to like about this chart --- CAGR of 54% is pretty amazing
0000peb.JPG
Come on, winner - you know better, don't you?
I guess if you would talk about earnings CAGR starting from a strong base, I could understand your excitement.
Unfortunately it is not.
It is their number of tests over the last two years, starting in the middle of the Covid pendemic, where bladder cancer was the last of anybody's worries.
They must have had similar numbers of tests already 10 years ago? Would have been difficult to achieve less growth, if you start at the absolute downpoint, isn't it?
Didn't one of their board members talk more than a decade ago talk about "hundreds of thousands of tests"? Stupid shareholders thinking at that stage about tests per quarter or similar - what he meant was the sum of all test accumulated over more than a decade ...
But hey - isn't it great to see that this company still manages to attract people happy to fund them ... clearly increasing the number of work opportunities in Dunedin ... and you are right ... maybe this is (after arriving the end of an excrutiating long and bumpy runway) the final takeoff. Could be ... and lets all cross fingers. Whether it works, though, we don't really know, don't we?
I liked this part of the update...
"These figures show the company has delivered a compound annual growth in test volumes since 2021 of 54%."
Market seems to believe it, so that's good (well, so far.....)
Quote from: Left Field on Jul 20, 2022, 10:56 AMI liked this part of the update...
"These figures show the company has delivered a compound annual growth in test volumes since 2021 of 54%."
Market seems to believe it, so that's good (well, so far.....)
Something just sounds wrong when anybody uses in 2022 the phrase "compound annual growth since 2021"
...
But hey - I am probably just picky. If the markets like it, it clearly must be good (for now). Love the hype curve.
Quote from: BlackPeter on Jul 20, 2022, 11:33 AMSomething just sounds wrong when anybody uses in 2022 the phrase "compound annual growth since 2021"
...
But hey - I am probably just picky. If the markets like it, it clearly must be good (for now). Love the hype curve.
Would have sounded better if they said 136% growth from 2 years ago
Quote from: winner (n) on Jul 20, 2022, 11:43 AMWould have sounded better if they said 136% growth from 2 years ago
The growth in the number of tests is positive news as is the growth in the number of clinicians using them. Both are off a low base of course but they are heading in the right direction.
Even more positive is the transparency around the numbers and the fact they will be reported on a quarterly basis from now on.
And more good news....
"DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces it has substantially completed a commercial agreement with the Southern District Health Region (SDHR) for the use of its non-invasive Cxbladder genomic biomarker tests.
The SDHR, which under the new Te Whatu Ora, Health New Zealand, has assumed administrative healthcare responsibility for 326,000 people across Otago and Southland, will deploy Cxbladder Triage into the primary care setting. Deploying into primary care follows the clinical practice model for hematuria evaluation (blood in the urine) established in the Canterbury health region. This deployment model provides care to the greatest number of patients and offers clinically actionable information at the earliest point in the patient care pathway.
The agreement with SDHR will mean that 15 of New Zealand's 20 administrative health regions, which together cover more than 75% of the country's population, will now have access to the test via public healthcare. Under the primary care model, General Practitioners will be able to order Cxbladder Triage to help safely de-intensify clinical workup for patients presenting with hematuria. In many cases this will reduce the need for secondary referral and an invasive cystoscopy."
https://www.nzx.com/announcements/395682
Always on the cards IMO, but still nice to see.
I'm getting the feeling that this new CEO is going to achieve great things for this company. Doing the mahi.
As Pierre notes the improved reporting and quarterly updates are a sign of confidence.
https://www.stuff.co.nz/business/opinion-analysis/129339375/after-two-decades-is-pacific-edge-turning-the-corner (https://www.stuff.co.nz/business/opinion-analysis/129339375/after-two-decades-is-pacific-edge-turning-the-corner)
Craig's latest Target price $.66
Use of Cxbladder as a 'top of funnel' test in NZ expanded
PEB has "substantially completed" an agreement with the Southern District Health Region (SDHR) to deploy PEB's Cxbladder Triage bladder cancer test for use by its GPs on patients presenting with hematuria (blood in the urine, the #1 bladder cancer symptom). Likely following the model established in Canterbury, SDHR patients presenting to their GP with hematuria could be tested with Triage & imaging. If results are; a) positive, they would be referred to a urologist to receive an invasive cystoscopy or b) negative, they would be managed by their GP. Clearly, the expansion of Cxbladder as a top of funnel test in NZ suggests it is proving effective for this use case. The NZ model where Cxbladder is used as a top of funnel test prior to deciding whether to administer a cystoscopy, is quite different to the current US model where urologists order a Cxbladder test in conjunction with a cystoscopy.
Expansion to primary care in the US could double the TAM...
The TAM for Cxbladder in NZ is small at c.$5m, and we estimate the direct financial upside from the potential SDHR deal at just c.$150k/yr. The more interesting questions are 1) whether the adoption of Cxbladder as a top of funnel test in primary care in NZ foreshadows similar adoption in the United States and 2) the implications for the TAM. Expanding the use case for Cxbladder to primary care in the United States would double the size of our TAM estimate from c.$3bn to c.$6bn. This reflects that while 3.4m hematuria patients require a urologist test workup per year (from which we estimate our $3bn TAM), around 7m present with hematuria (to GPs or urologists). Moreover, if Triage is adopted as a top of funnel test, there is potential for PEB's penetration of the TAM to be higher than our current 15% estimate.
...but more evidence is needed
Unfortunately, the SDHR agreement is unlikely to push the US towards usage of Cxbladder Triage as a top of funnel test anytime soon. We note that the public healthcare system in the much larger Canterbury region has been using Cxbladder in this manner since 2018, and this appears to have had no influence on US workflows to date. To see Triage adopted as a top of funnel test will first require demonstration of improved patient outcomes in upcoming US clinical trials. The nearest of these is the STRATA study, with full data collection targeted for 1Q23 and publication targeted for CY23. If this passes muster we still see the economics of marketing Cxbladder to the 200k GPs in the US as a significant barrier, requiring a targeted commercial strategy. At this stage we remain watchful. Neutral maintained
That's a gloomy report from Craig's eh share guy ....at least they didnt say SELL but then I doubt many of their clients have PEB
And that Stuff story linked used the term 'inflection point' but just any old inflection point as Jackie said it was a 'great inflection point' ......and saying that is often the kiss of death for many stocks
PEB share price should go up next week now.
Yes it is. I think they are generous at $.66. Lack lustre growth talked up.
LOT of talk over the last two decades and a LOT of "this capital raise will see us through to being cash flow positive" Frankly I have lost count of how many times I have heard it.
If my own personal experience is anything to go by you will find that Oncologists tell you that you can't beat doing a Cystoscopy https://www.webmd.com/prostate-cancer/guide/cystoscopy, sticking a camera on a tube up your manhood and having a really good look around. I can tell you from personal experience its not a pleasant experience and you leave your dignity at the door especially when they do a prostate examination for good measure as well.
Frankly I'd rather humiliate myself and be sure than take chances on a test that isn't 100% accurate and that's exactly how the Oncologist explained it to me.
Each to their own but for me they have talked far too much over the years and delivered far to little. I believe this market is in a state that basically says "show me the money" promises of growth don't cut the mustard any more.
For what its worth having turned 60 last year I no longer care about promises of possible great returns at some distant point...if something isn't eps positive and paying me at least 5%, preferably at least 7% gross, I'm not interested.
Quote from: Basil on Jul 24, 2022, 01:07 PMLOT of talk over the last two decades and a LOT of "this capital raise will see us through to being cash flow positive" Frankly I have lost count of how many times I have heard it.
If my own personal experience is anything to go by you will find that Oncologists tell you that you can't beat doing a Cystoscopy https://www.webmd.com/prostate-cancer/guide/cystoscopy, sticking a camera on a tube up your manhood and having a really good look around. I can tell you from personal experience its not a pleasant experience and you leave your dignity at the door especially when they do a prostate examination for good measure as well.
Frankly I'd rather humiliate myself and be sure than take chances on a test that isn't 100% accurate and that's exactly how the Oncologist explained it to me.
Each to their own but for me they have talked far too much over the years and delivered far to little. I believe this market is in a state that basically says "show me the money" promises of growth don't cut the mustard any more.
For what its worth having turned 60 last year I no longer care about promises of possible great returns at some distant point...if something isn't eps positive and paying me at least 5%, preferably at least 7% gross, I'm not interested.
Fair enough, but CXBladder is an accepted, accurate, non-invasive adjunct to a cystoscopy. It isn't designed to replace the cystoscopy but as an easy screening procedure that can even be done in one's home. If the result indicate a problem, then a follow up cystoscopy is required. It has cleared all the trials, testing and regulatory hurdles and has been endorsed by many of the larger health care providers in the US, including Medicare and MedicAid. The question is, now that the hard work has been done, are we at a cusp of an acceleration in it's use? I'm prepared to be wrong, but I'm getting a good feeling from the increasing numbers and the confidence shown by PEB in starting quarterly reporting off those numbers. Too soon to say "inflection point" (which as you say, is often the kiss of death) but I think the next 12 months will determine whether PEB take off, or ultimately fade away.
AGM this week. Insert from Forbars most recent note. Forbar have target price of $1.05 "Outperform"
Hopefully after two positive anouncements the AGM will offer further insight.
Limited outlook commentary although momentum appears to be improving
COVID-19 has had a profound impact on PEB's ability to drive revenue growth, with limited urologist access for PEB's sales reps. However, against this backdrop following its CMS coverage decision and Kaiser agreement in mid-2020 PEB has grown revenue at a FY20–FY22 CAGR of +63% (off a low base). Outlook commentary lacked quantitative details, however, as the prevalence of COVID-19 abates recent signs showcase an uptick in throughput with "average weekly test throughput in the US from the start of April to last week, +25% higher than the average of the last year". In addition, we estimate total USA lab throughput in April is up ~+60% versus the end of FY21 on the back of a material increase in volumes through April. Over the near/medium-term we see a number of catalysts that have the potential to drive the share price (including Kaiser Permanente ramp up, new commercial agreements, stronger mention/inclusion in guidelines, and further clinical evidence).
PEB investing in key people, and adding to their payroll costs.
https://www.directbroking.co.nz/DirectTrade/dynamic/announcement.aspx?id=6081679
Always a fine line for small cap companies, balancing the management of what little cash they have, while seeking to expand their expertise and market clout.
Interesting times.
Quote from: Left Field on Jul 28, 2022, 10:41 AMPEB investing in key people, and adding to their payroll costs.
https://www.directbroking.co.nz/DirectTrade/dynamic/announcement.aspx?id=6081679
Always a fine line for small cap companies, balancing the management of what little cash they have, while seeking to expand their expertise and market clout.
Interesting times.
I think this appointment shows the new MD is really serious about driving growth for PEB. The company has a significant war chest from the recent cap raise so funding is not an issue - and wont be in the future as the top line continues to improve.
Peter Meintjes impressed me at the Annual Meeting as confident, intelligent and knowledgeable and to have a clear strategy for growth. It was obvious from his comments there is a great degree of complexity to be navigated in the US market but, in conjunction with the equally impressive David Levinson on the US side, I feel the company is in very good hands and the future is bright.
It was especially pleasing to hear the chairman state that the company believes it has sufficient financial resource to take the company through to cash flow positivity and profitability without requiring an additional capital raise.
Thanks Pierre for the update. No more additional capital raises is great news. Yes seems very positive.
Quote from: Pierre on Jul 28, 2022, 04:35 PMPeter Meintjes impressed me at the Annual Meeting as confident, intelligent and knowledgeable and to have a clear strategy for growth. It was obvious from his comments there is a great degree of complexity to be navigated in the US market but, in conjunction with the equally impressive David Levinson on the US side, I feel the company is in very good hands and the future is bright.
It was especially pleasing to hear the chairman state that the company believes it has sufficient financial resource to take the company through to cash flow positivity and profitability without requiring an additional capital raise.
With all due respect we have heard exactly that so many times before I have lost count.
From memory Forbar have been involved in quite a number of those capital raises so who are they really acting for when they come out with a positive outlook ? Independent research for clients of earning Brownie points towards more investment banking business ?
Until they really are eps positive with a bright outlook I think a VERY high degree of caution is warranted with any forward looking statements this company makes
Quote from: Basil on Jul 28, 2022, 05:18 PMWith all due respect we have heard exactly that so many times before I have lost count.
From memory Forbar have been involved in quite a number of those capital raises so who are they really acting for when they come out with a positive outlook ? Independent research for clients of earning Brownie points towards more investment banking business ?
Until they really are eps positive with a bright outlook I think a VERY high degree of caution is warranted with any forward looking statements this company makes
I can't recall ever hearing such a positive comment about cash from the company, but even if they have said it before, this time it is certainly a credible statement when they are holding around $100m from last year's cash raise.
I am well aware you are not a PEB fan, and for many shareholders - me included- it has been a roller coaster ride over the years. Still, in 2-3 years time you might be regretting you didn't buy a ticket.
PEB FY22 at 280722.jpgPEB FY22 at 280722.jpgPEB FY22 at 280722.jpg
Thanks Pierre, these slides from the FY22 presentation sum up PEB's position v well IMO.
REALLY BIG NEWS on the way ..... or maybe takeover (ie get out of jail card) at $1.50
Trading halt can't be for anything bad
Quote from: winner (n) on Jul 29, 2022, 10:21 AMREALLY BIG NEWS on the way ..... or maybe takeover (ie get out of jail card) at $1.50
Trading halt can't be for anything bad
Exciting, roll on Monday's news!
FWIW - I would prefer a partial acquisition/investment in PEB from a major strategic partner to help strengthen the balance sheet and take the company forward. Imagine FPH buying in. Crikey.
ps link to ODT article on yesterday's ASM. https://www.odt.co.nz/business/pacific-edge-focus-building-sustainable-value
Quote from: Pierre on Jul 28, 2022, 06:11 PMI am well aware you are not a PEB fan, and for many shareholders - me included- it has been a roller coaster ride over the years. Still, in 2-3 years time you might be regretting you didn't buy a ticket.
Depending on what the Trading Halt is about, Basil Beagle may be regretting he didn't buy a ticket for the PEB roller coaster yesterday. ;D
I added to my position after looking at the AGM yesterday. This halt could also be bad news.......
Shareholders were clearly advised at yesterday's meeting the company has no need for a cap raise, nor is it listing on the NASDAQ - they would only do that to raise cash.
It's hard to imagine some incredibly bad news has arisen overnight so I am optimistic we can expect something positive from this Trading Halt.
Quote from: Pierre on Jul 29, 2022, 11:06 AMDepending on what the Trading Halt is about, Basil Beagle may be regretting he didn't buy a ticket for the PEB roller coaster yesterday. ;D
The very well fed dog is more than content to leave speculative companies to others. Good luck.
Quote from: winner (n) on Jul 29, 2022, 10:21 AMREALLY BIG NEWS on the way ..... or maybe takeover (ie get out of jail card) at $1.50
Trading halt can't be for anything bad
Reasons for trading halt:
Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) became aware overnight (NZT) of the inclusion of Cxbladder CPT codes in a draft proposal for a different approach to determine which cancer biomarker tests are eligible for reimbursement by Novitas.
The publication of the proposed approach for Genetic Testing in Oncology is set out in a draft Local Coverage Determination (LCD, DL39365) and a draft Local Coverage Article (LCA, DA59125).
Pacific Edge will provide its shareholders with further clarification of the implications for Pacific Edge once it has received advice from its US legal team and other advisors prior to lifting the current trading halt.
The trading halt will remain in place until a further announcement from PEB on Monday 1 August 2022, with trading expected to resume at market open on Monday, 1 August 2022.
We confirm that we are not aware of any reason why the trading halt should not be granted. Yours sincerely
Looking like cover may of been removed
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59124&ver=8
Quote from: Shareguy on Jul 29, 2022, 01:51 PMLooking like cover may of been removed
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59124&ver=8
Doesn't look that good does it shareguy
And everybody was on cloud 9 yesterday afternoon.
Hope it turns out OK
Quote from: Shareguy on Jul 29, 2022, 01:51 PMLooking like cover may of been removed
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59124&ver=8
Too early to judge....
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
I blame Winner for getting me excited...
Glad I went for a walk instead of buying that new Porche lol!
This is the original NZX announcement of coverage.(3/7/20) with CX Bladder codes 0012M and 0013M.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/355757/325821.pdf
My read with the "Draft" changes to MCD is that these codes have been added to group 6. If you look further down the CMC doc, it states group 6 non covered CPT codes.
So yes it's only a "draft" but I take it to be terrible news which is going to have a "material negative impact on the share price.
Note: I could be reading this completely wrong and the announcement is stated as a "draft"
Quote from: Shareguy on Jul 29, 2022, 02:56 PMThis is the original NZX anouncement of coverage.(3/7/20) with CX Bladder codes 0012M and 0013M.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/355757/325821.pdf
My read with the "Draft" changes to MCD is that these codes have been added to group 6. If you look further down the CMC doc, it states group 6 non covered CPT codes.
So yes its only a "draft" but I take it to be terrible news which is going to have a "material negative impact on the share price.
Note: I could be reading this completly wrong and the anouncement is stated as a "draft"
In the words of our Dave this could be 'transformational'
But you'd think that things can't turn to custard so quickly
It does not look good.
CMS makes up 65% of revenue in the USA currently. Now just two short years after being accepted they are removed (I'd be very interested to know why).
Share price will be absolutely devastated regardless of it being a draft.
Scare over?
https://www.nzx.com/announcements/396175
Lawyers likely to benefit.
"Having consulted with our US-based advisers and industry experts, Pacific Edge believes the proposed changes are unlikely to survive the ongoing review process in their current form. The consensus view we received was that the proposed changes to the LCD are contrary to US legal requirements and precedent. The proposed changes also fundamentally change the process for determining coverage for specific tests and could deprive US clinicians and Medicare patients access to diagnostic tools with proven, peer-reviewed clinical utility."
"Pacific Edge Chief Executive Dr Peter Meintjes says, "We commend the broader initiative to simplify and streamline the coverage process. However, given the explicit prior coverage and payment history for Cxbladder tests, we have presented our initial concerns to Novitas.
"We will work with CMS and its contractors to make the necessary changes to the drafts to ensure that there is no disruption to the coverage of Cxbladder, as far as we are able. We will also be encouraging the many clinicians and healthcare providers already using our tests to support our position. We will update shareholders as we progress this matter."
So all this was known back in June
Strange Jackie Walker - US CEO - decided to retire in June
Wondered at time why when PEB was on the cusp of greatness she'd walk away from something she had worked on for years with seeing it all come to fruition
Interesting conspiracy theory Winner.... maybe QAnon also involved??
I'm more inclined to the following comment; "the proposed changes to the LCD are contrary to US legal requirements and precedent."
Any SP slump on speculation (such as Winner's theory) will only strengthen PEB's legal case IMO.
40 cents now
Blood on the streets.
Yep = fear is driving the market and it's a real opportunity for those with steady hands and can see the bigger picture. In all likelihood the changes will not go ahead, but even if they do it will only be a portion of PEBS customers (albeit an importan) one, and will be replaced by other providers in the US and elsewhere as the uptake of CXBladder continues to accelerate - which I believe it will. At 40c it's very tempting to buy a bit more and either hold or sell when the re-bound occurs. Nerves of steel required at this juncture.
Well what to do. Firstly this is a "Draft" and may or may not actually happen. Secondly its not 100 percent of the US market. My concern was if there is some doubt over the test results. I spent the weekend looking at the latest research done on CX bladder and determined that "all is good"
I doubled my position this morning at $.40 a share.
Quote from: LoungeLizard on Aug 01, 2022, 10:17 AMYep = fear is driving the market and it's a real opportunity for those with steady hands and can see the bigger picture. In all likelihood the changes will not go ahead, but even if they do it will only be a portion of PEBS customers (albeit an importan) one, and will be replaced by other providers in the US and elsewhere as the uptake of CXBladder continues to accelerate - which I believe it will. At 40c it's very tempting to buy a bit more and either hold or sell when the re-bound occurs. Nerves of steel required at this juncture.
Bigger picture for PEB is quite easy to see.
Draw a flat line with two similar sized hype - peaks, and currently SP swiftly sliding down the second hill.
Always full of promises (must be time to celebrate 2 decades of empty promises), but never delivered ... unless to management. I heard they built some nice decks. PEB thread on the other forum makes an interesting reading for anybody who wants to learn.
Anyway - good to see that they still attract a crowd. Shows that it is well possible to entertain the crowd with endless repetitions ... no need to think about anything new to separate some punters from their money.
Sure PEB is risky yet some purchasers taking on that risk today.
IMO it's all about working hard to get your DCA low enough to allow for perceived risks (and this applies to all small caps.)
GLH.
(PX1 today is a contrasting small cap example where the news changes to the upside giving impressive gains to holders.)
Just got this email from PEB
Pacific Edge Comments on Proposed Novitas LCD - Frequently Ask Questions
Dear Shareholder,
Frequently asked questions regarding our commentary on the proposed Novitas LCD:
Is Cxbladder still being reimbursed in the US?
Yes. But Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge's US laboratory in Hummelstown, Pennsylvania, has proposed changes to the Local Coverage Determination (LCD) that governs the reimbursement of Cxbladder tests in the US. These proposed changes have the potential to disrupt reimbursement for patients with Medicare and Medicare Advantage plans accounting for a significant part of the current Cxbladder testing revenue.
What is a Medicare Administrative Contractor (MAC)?
The Centers for Medicare and Medicaid Services (CMS), relies on a network of MACs to serve as the primary operational contact between the Medicare fee for service (FFS) program and the health care providers enrolled in the program. MACs perform many activities including establishing Local Coverage Determinations (LCDs), which are decisions to cover a particular item or service in a MAC's jurisdiction.
What is a Proposed LCD?
MACs such as Novitas, periodically propose new LCDs on whether to cover a particular item or service in a MAC jurisdiction (region). As Novitas notes on its website: "Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor".
What has Novitas proposed?
In June Novitas proposed to fundamentally change its approach to determining if a genetic/genomic test should be reimbursed for Medicare patients in the US. Specifically, Novitas has proposed a new approach to coverage in a draft LCD (DL39365/DL3967) and a draft Local Coverage Article (LCA, DA59125) for Genetic Testing in Oncology. Under its current local coverage determination, Novitas reviews the clinical evidence for individual diagnostic products. Going forward, Novitas is proposing that it will determine which tests to cover by relying solely on criteria established by third party external knowledge bases: (1) Clinical Genome Resource (ClinGen); (2) National Comprehensive Cancer Network (NCCN); or (3) Oncology Knowledge Base (OncoKB).
How does the new approach impact Cxbladder and Pacific Edge?
If the proposed LCD and LCA were approved unchanged, Cxbladder would no longer receive reimbursement for Cxbladder from Novitas as the tests are not specifically mentioned in any of the three knowledge bases that Novitas has identified. OncoKB and ClinGen are "SNP3-only" databases, meaning that they are unsuitable for multi-analyte assays with algorithmic analyses (MAAAs), so advanced gene expression tests would only be able to obtain coverage by inclusion in NCCN guidelines.
What does Pacific Edge think of the LCD and LCA?
Pacific Edge believes the proposed LCD and LCA will not survive in their current form because:
• They do not meet the statutory requirements for an LCD.
• They do not comply with CMS' requirements for the development of LCDs.
• Their new approach of using knowledge bases as a determinant for CMS coverage is not well supported within the draft LCD.
• The proposed LCD and LCA are insufficient to allow stakeholders to understand whether tests are covered and would inappropriately restrict coverage for tests.
What is Pacific Edge doing to change the Novitas proposal?
Pacific Edge has presented in person to Novitas and has made a detailed submission comprehensively setting out its concerns and the drawbacks of this new approach. It is also sharing insight with other biotech companies that could be similarly affected by the new approach to make their concerns known to Novitas before the end of the consultation period, and engaging with industry advocates.
If the draft LCD was first published in June, why did Pacific Edge only notify the NZX and ASX and call a trading halt on Friday 29 July 2022?
In June the draft proposals did not appear to affect Pacific Edge since there was no indication that coverage for Cxbladder under its existing LCD was changing. Additionally, Cxbladder was not explicitly mentioned in the proposed LCD. However, on Friday morning on 29 July 2022 (NZT), the company became aware that the latest revision of the draft explicitly excluded Cxbladder from reimbursement. In consultation with the NZX, Pacific Edge decided a trading halt was appropriate because there was information in the public domain that needed clarification and context. Given the time differences between New Zealand and the United States, where the subject matter experts are based, and the complexity of the proposals, a full and complete response was not able to be completed within a reasonable time, resulting in a request for a trading halt.
When will Pacific Edge know if the proposed LCD is finalized?
Novitas is required to give Pacific Edge at least 45 days' notice of the effective determination date. Novitas is consulting interested parties on the proposals until 6 September 2022. Novitas has not provided a specific date for a decision, but it must either publish or withdraw the draft LCD within a year of the end of the public comment period.
Thanks Shareguy, impressive response by PEB IMHO.
Quote from: Shareguy on Aug 01, 2022, 10:43 AMWell what to do. Firstly this is a "Draft" and may or may not actually happen. Secondly its not 100 percent of the US market. My concern was if there is some doubt over the test results. I spent the weekend looking at the latest research done on CX bladder and determined that "all is good"
I doubled my position this morning at $.40 a share.
If you do well you might get a new teak deck out of it. ;) Management already have theirs's :D
Quote from: BlackPeter on Aug 01, 2022, 10:48 AMBigger picture for PEB is quite easy to see.
Draw a flat line with two similar sized hype - peaks, and currently SP swiftly sliding down the second hill.
Always full of promises (must be time to celebrate 2 decades of empty promises), but never delivered ... unless to management. I heard they built some nice decks. PEB thread on the other forum makes an interesting reading for anybody who wants to learn.
Anyway - good to see that they still attract a crowd. Shows that it is well possible to entertain the crowd with endless repetitions ... no need to think about anything new to separate some punters from their money.
You could do that exercise with just about any speculative stock and come to the same conclusion. If I had done that exercise with A2 in the early days I would never have bought in at 50c and sold at $20. That's what these sort of stocks offer - a potential life changing windfall. It really all depends on one's risk/reward calculation. Most investors' portfolios have a small amount on calculated gambles. Nothing wrong with that. PEB for me is still the best of the more speculative stocks around, this current dip notwithstanding.
Quote from: LoungeLizard on Aug 01, 2022, 11:22 AMYou could do that exercise with just about any speculative stock and come to the same conclusion. If I had done that exercise with A2 in the early days I would never have bought in at 50c and sold at $20. That's what these sort of stocks offer - a potential life changing windfall. It really all depends on one's risk/reward calculation. Most investors' portfolios have a small amount on calculated gambles. Nothing wrong with that. PEB for me is still the best of the more speculative stocks around, this current dip notwithstanding.
Exactly and ditto for me too!
Quote from: Left Field on Aug 01, 2022, 11:46 AMExactly and ditto for me too!
And me - speculative holdings in PEB, PX1, and BLT - but my ridiculously overweight "non speculative" holding is unfortunately in OCA
20 years of failure to generate returns to shareholders after tapping them so many capital raises I have lost count. The repeated claims that this capital raise will see us through to positive cash flow is what I think is especially egregious.
These guys make wildcat oil drilling companies look like a much better gamble, or red or back on the roulette wheel, at least SKC management only take a few percent cut.
CEO says just a "bump in the road"
Insert from today
The company raised $103.5m last October in advance of a big sales push into the US. Meintjes said he didn't plan to alter plans to ramp up their sales activity in the US. "I don't think we are going to change course. But we will make sure that we have plans for a worst-case scenario.
"And, again, we believe that a worst-case scenario is a bump in the road, because studies that we already have are designed to get increasing coverage for CXbladder. So, if we end up in a situation where we lose coverage, it will be temporary, because the evidence that we're generating will allow us to quickly gain coverage."
Quote from: Basil on Aug 01, 2022, 01:04 PM20 years of failure to generate returns to shareholders after tapping them so many capital raises I have lost count. The repeated claims that this capital raise will see us through to positive cash flow is what I think is especially egregious.
These guys make wildcat oil drilling companies look like a much better gamble, or red or back on the roulette wheel, at least SKC management only take a few percent cut.
Not a fan then, we get that. And if I had bought in only at the latest cap raise of $1.35, I might agree with you.
But the thing is, most of us who have backed this horse have been playing the long game, which is the only thing you can do for this type of stock. In my case, the long game isn't even that long - I bought most of my holding just over two years go at 15c. Even after having participated in the latest cap raise, my average price is still only around 20c. So even at todays prices it's worked out fine.
But even if you want to go back further, say a decade or more of "ups andowns" you would have bought in at around 10c. At the current, diminished price that's still a 5x gain.
So it depends on when you bought in and as I say, your appetite for risk, and ability to ride the punches. I'm not a trader who sells and buys on the ups and downs and PEB is not that type of stock, although a trader could have made a 20% gain on just todays high and low. I'm pretty confident that proposed reimbursement changes that will negatively affect PEB won't go through. If they don't I reckon people who bought in today will double their money in 6 months. ;D
$.55
Craigs say "Drafts" of this type are often rescinded.
Medicare coverage of Detect & Monitor could be lost
On Friday PEB went into a trading halt, citing proposed changes to a key
document which enables Detect and Monitor to be reimbursed by Medicare,
the US government insurer which provides healthcare coverage to c.65% of
PEB's target population and the majority of PEB's revenue. The key change is
that Cxbladder will now need to be included in NCCN (a key US oncology
industry body) clinical guidelines for Medicare to reimburse the product (vs
current need to be for a valid medical purpose). These changes were
proposed by Novitas, a company to which Medicare outsources decisions to
cover diagnostic tests. The proposals are open for feedback from industry
participants and clinicians until Sep 6th, a process during which it will be
critical for PEB to gather support to push back against the draft proposal.
Best case scenario could see "business as usual" by September
The best case scenario would involve the proposed draft being rescinded
following a period of public comment, or the draft being published but with
all mention of Cxbladder removed. We see this scenario as more likely given
1) Detect and Monitor had demonstrated enough clinical utility data to
warrant Medicare coverage in 2020 - since then test utility data has only
improved 2) drafts of this type are frequently rescinded
Shareholders update....tracking along nicely.
https://www.nzx.com/announcements/400636
"In the three months to the end of September (Q2 FY23) total test volumes processed in the company's laboratories were 7,861 up 36% on the 5,780 tests processed in the same quarter of the prior year and up 11% on the 7,055 tests processed in the three months to the end of June 2022 (Q1 FY23). Volumes for the quarter are 36% more than the average volumes recorded in the 2022 financial year.
For the six months to the end of September 2022, Pacific Edge processed 14,916 tests in its laboratories, a figure that represents a 34% increase on the 11,136 tests processed in the same period in the prior financial year. "
Plus this update re Novitas:
Pacific Edge maintains that in the absence of any adverse reporting event about the performance
of Cxbladder, it would be unprecedented to lose coverage. To this end, we have offered comments on the proposal (see page 4).
We maintain our position that the proposed LCD is unlikely to survive in its current form and continue to responsibly plan for all eventualities.
We look forward to providing a further update when we release our half year financial results on 24 November 2022.
More info here; https://www.pacificedgedx.com/assets/Investor-Files/Investor-Updates/PEB-Investor-Update-Oct22.pdf
Based on today's news there was a tempting opportunity to re-purchase shares sold at 1.30 back in Dec 2021.
Plenty of upside from today's VWAP of .47c provided the 24 Nov update continues today's positive theme.
What could possibly go wrong?
This posted by Defater on the other forum;
"Minerbarejet (Miner) Died on Friday. He had a Brain Bleed at his home in Hawera and died later that day of a stroke at the New Plymouth Base Hospital. I played golf with Sandy for years and worked beside him for 17 Years at Silver Fern Farms Beef Processing Plant where he was the Stock Grader. He was very intelligent, witty and loved a glass of red wine. I'm sure his comments will be missed by all here. If there are any messages for his wife (Julie) and family I will print them and pass them on as Julie does not use the computer. Sandy's funeral is this Thursday 10th November. RIP Miner."
I will miss his informed posts. A very intelligent observer and friend of PEB.
Miner had unshakeable faith in CDY/ AN1 on the ASX too. It's sad that they never came close to repaying this. He was very well read on both CDY and PEB. Moenga roa.
$51 cents. Has been slowly going up. Apart from investor update on the 24th and other news?
Quote from: Shareguy on Nov 16, 2022, 01:12 PM$51 cents. Has been slowly going up. Apart from investor update on the 24th and other news?
Speculation on the outcome of the Novitas coverage review that PEB is hoping to give alongside the 1H FY23 update next week (See post #76 above.)
Good chance it will be favourable.
Up about 17% on recent lows.
There's an old saying...... something about 'following the trend till the bend in the end.'
And there's another old TA saying about 'gaps have to be filled.'
There's a lot of old sayings.....
1H FY23 Results out.... not bad IMHO..... but no Novitas update.....yet.
https://www.nzx.com/announcements/402943
HIGHLIGHTS
• Operating revenue from test sales increases 62% to $8.7 million when compared to the same period of the prior year (1H22); total revenue increases 102% to $13.6 million when compared with 1H22, with increases from commercial test volume growth boosted by foreign exchange gains
• Total laboratory throughput rises 34% to 14,917 in line with analyst expectations, lifted by a 35% increase in commercial test volumes to 12,422, with growth led by the US market
• Investments driving Cxbladder adoption and lifting US clinician engagement; staff numbers increase from 86 at the end of March 2022 to 100 full-time-equivalents (FTE) at 30 September 2022
• Kaiser Permanente using Cxbladder Triage at 11 sites, two of which are in the Top 20 sites by volume during 1H23
• Net losses after tax increased to $10.6 million, from $9.0 million in 1H22 as Pacific Edge continues to invest for growth
• Cash, cash equivalents and short-term deposits of $93.5 million as at 30 September 2022, down from $105.4 million at 31 March 2022, provides strong foundation for continued investment
• Optimistic outlook tempered by proposed LCD from Novitas and the potential to affect Medicare reimbursement.
Out of a morbid fascination of this company I looked at the Balance Sheet
Accumulated Losses rolled over the $200m mark
Another milestone met?
Quote from: winner (n) on Nov 24, 2022, 09:00 AMOut of a morbid fascination of this company I looked at the Balance Sheet
Accumulated Losses rolled over the $200m mark
Another milestone met?
Don't you remember the millions of tests they promised 15 or so years ago? Was probably just a typo, they meant millions of losses ...
Clearly, they not just kept their promise, but overdelivered ...
The market not too fussed by the results so far today.
Clearly the uncertainty surrounding the unresolved Novitas proposal is hurting.
"As we look towards the long-term, the proposed LCD from Novitas has been
factored into the phasing of our investment program. At present, we continue
to be reimbursed by Medicare for our tests and have not seen any reduction in
demand for Cxbladder since the release of the proposed LCD. Pacific Edge
maintains that in the absence of any adverse reporting event on the
performance of Cxbladder, it would be unprecedented to lose CMS coverage.
BIG news
All falling into place
Marked Price Sensitive so must be BIG news
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/403937/385487.pdf
All that matters is that the market likes today's announcement....
up 7% today to approx 49.5c
no doubt a few more valuable patents to store in the cupboard too..
Next news should be a satisfactory conclusion to the draft Novitas reimbursement proposal.
Onwards and upwards.
Lot of end of trading action today - 1.2M shares traded up 7.4% to 51c 8)
Another brick in the wall....... not exactly overwhelming, but progress just the same.
https://www.nzx.com/announcements/405289
A positive Novitas decision is really needed to shake up the SP
Quote from: Left Field on Jan 13, 2023, 10:18 AMAnother brick in the wall....... not exactly overwhelming, but progress just the same.
https://www.nzx.com/announcements/405289
A positive Novitas decision is really needed to shake up the SP
Yeah, it's the second coming of this announcement. The contract signing was delayed. Apparently they had issues with the pen. (https://www.youtube.com/watch?v=2Encm187scA&ab_channel=GuardianNews)
Quote from: Left Field on Jan 13, 2023, 10:18 AMAnother brick in the wall....... not exactly overwhelming, but progress just the same.
https://www.nzx.com/announcements/405289
A positive Novitas decision is really needed to shake up the SP
Novitas and the completion of the electronic interface into the Kaiser Permanente EMR system.
Quote from: Left Field on Jan 13, 2023, 10:18 AMAnother brick in the wall....... not exactly overwhelming, but progress just the same.
https://www.nzx.com/announcements/405289
A positive Novitas decision is really needed to shake up the SP
Without wanting to get political I thought the whole idea of our health sector reform was to have one centralized body. So how is it that this agreement is just for the Southern District Health Board.
Quote from: Minimoke on Jan 13, 2023, 03:01 PMWithout wanting to get political I thought the whole idea of our health sector reform was to have one centralized body. So how is it that this agreement is just for the Southern District Health Board.
Sthn District Health Board was one of the few NZ Health Boards holding out on PEB..... (bit of irony as Dunedin is the home for PEB) and of course all this will be hypothetical if/when all the health boards are amalgamated and PEB becomes standard across NZ...(and yes, best not to get political.)
We must be due for the 3rd quarter update.
When's the next capital raise? I say this tongue in cheek because I have lost count of how many times they have raised new capital with promises that raise will see them through to profitability and here we are 20 years after listing and they're still losing money. So what if the southern DHB is going to use their stuff...YAWN.
They have $100m in the bank or close too it so there shouldn't be any need to have one.
Quote from: Greekwatchdog on Jan 13, 2023, 04:10 PMThey have $100m in the bank or close too it so there shouldn't be any need to have one.
Might need to do a capital return?
Quote from: Basil on Jan 13, 2023, 03:50 PMWhen's the next capital raise? I say this tongue in cheek because I have lost count of how many times they have raised new capital with promises that raise will see them through to profitability and here we are 20 years after listing and they're still losing money. So what if the southern DHB is going to use their stuff...YAWN.
I gave up watching PEB years ago. Seems like they always had their hand out and US approval was always just around the next corner. I recall there was a bit of excitement with the Kaiser approval. But that only gave it a short term lift of the SP
I see in last report "The half year net loss after tax increased to $10.6 million, from $9.0 million in 1H22"
So seems they still arent making any money
Nice to see savvy investors Harbour buying a few more PEB lately.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/405498/387175.pdf
Even nicer that their DCA is still well north of mine!
PEB update test volumes up 36%.... sounding positive on Novitas..... tho' still no official word.......
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/405516/387209.pdf
Test volumes for the third quarter of the 2023 financial year are up 36% on the same period in the prior financial year to 7,768.....
...We continue to actively engage with our legal advisors, our industry coalition partners and with all appropriate formal channels with Novitas and CMS regarding the proposed LCD and remain confident that our feedback will be incorporated into revisions to the proposal....
( Note the words "engage with our Legal advisors" in that quote..... let's hope it doesn't get to that.)
That release is a masterclass in smoke and mirrors
Big Headline trumpeting test volumes up 36%
Actual test figures in the body of the release
Quarter 2 2023 - 7864
Quarter 3 2023 ( this update ) - 7768
In old maths that is a drop quarter on quarter....
8)
Quote from: winner (n) on Jan 13, 2023, 04:32 PMMight need to do a capital return?
LOL, maybe they have enough cash to get through to when they might be eventually profitable, (losing $10.6m in the last half is quite an "accomplishment" for a company that's been trading and losing money for 20 years), but I think, not and certainly wouldn't punt my hard earned on this highly speculative "opportunity".
At the current rate of losses that $100m will all be gone in the next 5 years and then they can do another capital raise and tell the next bunch of gullible punters that success is just around the corner....the same B.S. they told everyone in every one in all their other capital raises than number so many I have lost count. Surely there's a limit to how many times you can cry "wolf" before everyone says this is a not a viable company?
Quote from: Crackity on Jan 19, 2023, 10:16 AMThat release is a masterclass in smoke and mirrors
Big Headline trumpeting test volumes up 36%
Actual test figures in the body of the release
Quarter 2 2023 - 7864
Quarter 3 2023 ( this update ) - 7768
In old maths that is a drop quarter on quarter....
8)
Exactly. Not good at all. It all rests on novitas decision. Even then sales growth hardly stunning. Got to laugh at graph. Looking for exit.
Mmm not sure about smoke and mirrors.
If there is a trend it is that Qtr 3 sales are traditionally weaker than Qtr 2. Such a trend is normally called 'seasonality.'
Here's what PEB said, "Volumes were flat on the Q2 23's 7,864 tests reflecting the traditional
slowdown the company sees from Thanksgiving through to the New Year and the
start of the fourth quarter. As the company has seen in prior years, it
expects a return to quarter-on-quarter growth in Q4 23."
In addition PEB are talking 'volumes' not revenue. I'll make my judgement when I see Qtr 4 figs.
Another brick in the wall.......
https://www.pacificedgedx.com/news-and-events/news/2023/pacific-edge-to-showcase-leading-biomarker-strategies-for-the-evaluation-and-management-of-bladder-cancer-at-sesaua/
Quote from: Left Field on Mar 08, 2023, 04:03 PMAnother brick in the wall.......
https://www.pacificedgedx.com/news-and-events/news/2023/pacific-edge-to-showcase-leading-biomarker-strategies-for-the-evaluation-and-management-of-bladder-cancer-at-sesaua/
Not a good analogy that another brick in the wall
Sounds like they building this Great Wall ...a barrier to stop users using their products
Quote from: winner (n) on Mar 08, 2023, 04:40 PMNot a good analogy that another brick in the wall
Sounds like they building this Great Wall ...a barrier to stop users using their products
Building an IP Moat or Wall a cool strategy these days...
However many punters still blinded by former CEO's glossy claims and not appreciating the odds for a favourable resolution of the Novitas funding proposal.
Another brick in the wall Leftie ...hope the wall don't tumble down
Got an email telling me this
The independent study2 is to be published in the prestigious journal Urologic Oncology and was undertaken at the University of California San Francisco (UCSF) and the University of Michigan. It examined whether a negative Cxbladder Monitor test could safely postpone a patient's next scheduled cystoscopy, the current 'gold standard' for bladder cancer surveillance.
Suppose this is good news
Must have been worried about the share price falling into the 30's so came out with something
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/409266/391796.pdf
Quote from: winner (n) on Mar 31, 2023, 09:04 AMSuppose this is good news
Must have been worried about the share price falling into the 30's so came out with something
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/409266/391796.pdf
Totally irrelevant to what is most critical to PEB's future - what is happening with the LCD coverage?
Quote from: Teitei on Mar 31, 2023, 09:22 AMTotally irrelevant to what is most critical to PEB's future - what is happening with the LCD coverage?
Exactly. And another president appointed last week draining the trough even further.
For Bar put an Analysis on this today. The longer it takes is better for PEB. Short version.
It has been 206 days since Pacific Edge's (PEB) Local Coverage Determination (LCD) comment period ended. We have undertaken thorough analysis of every proposed LCD since 1 January 2010. In this time there have been 2,013 unique proposed LCDs. Of these 84% have been finalised (unfavourable for PEB). Despite this evidence, our analysis shows that as time passes the odds tilt in PEB's favour. Of LCD decisions over 200 days, the odds of finalisation reduce dramatically with only 55% finalised (versus 92% for those under 200 days). We retain our NEUTRAL rating. Our analysis shows (1) the odds are evenly split at this point in the process, and (2) the stock price broadly reflects the current balance of probabilities. It is a binary outcome and we expect the stock price to remain range bound until we get increased clarity.
Most LCDs are finalised but as time passes the odds tilt in PEB's favour
On 1 August 2022, PEB confirmed notification of Cxbladder codes in a proposal for a different approach to determine which cancer biomarker tests are eligible for reimbursement. If finalised, PEB will no longer receive reimbursement payments for its CMS tests (~80% of FY23 sales). Novitas must finalise or reject the draft LCD within a year of the announcement date (28 July 2022).
In the 206 days since PEB's comment period ended we have learnt very little about whether the proposal will go ahead or not. We have undertaken a thorough exercise by analysing all 2,013 unique LCDs that have occurred since 2010 to understand (1) the finalisation rate of proposed LCDs, and (2) the decision timeframes. We acknowledge this analysis isn't perfect given the nuanced nature of each LCD, and PEB is of the view the proposal won't go ahead, but history is ultimately our most useful indicator.
Decision outcome — the majority of LCDs are finalised: 84% of LCDs have been finalised, 13% rejected and 3% are still pending.
�������Decision timeframes — finalised LCDs are much shorter than rejected LCDs: Of all finalised LCDs, the median time to decision is 69 days. Of all rejected LCDs, the median time to decision is 182 days. By Bayesian inference, the probability reduces dramatically for those decisions that occur after 200 days — 55% finalisation rate for those over 200 days versus 92% for those under 200 days.
Breaking it down — Novitas, molecular diagnostics and National Comprehensive Cancer Network (NCCN)
To further add to our analysis we have specifically filtered for LCDs related to Novitas, molecular diagnostics, and NCCN references.
Novitas appears more stringent relative to other contractors: 93% of its LCDs have been finalised.
�������Molecular diagnostics: 74% have been finalised. Median finalisation time of 119 days and median rejection time of 221 days.
NCCN: 296 LCDs had some reference to NCCN, only PEB's current proposal specifically uses guidelines as a coverage criteria.
Quote from: Greekwatchdog on Mar 31, 2023, 09:47 AMFor Bar put an Analysis on this today. The longer it takes is better for PEB. Short version.
It has been 206 days since Pacific Edge's (PEB) Local Coverage Determination (LCD) comment period ended. We have undertaken thorough analysis of every proposed LCD since 1 January 2010. In this time there have been 2,013 unique proposed LCDs. Of these 84% have been finalised (unfavourable for PEB). Despite this evidence, our analysis shows that as time passes the odds tilt in PEB's favour. Of LCD decisions over 200 days, the odds of finalisation reduce dramatically with only 55% finalised (versus 92% for those under 200 days). We retain our NEUTRAL rating. Our analysis shows (1) the odds are evenly split at this point in the process, and (2) the stock price broadly reflects the current balance of probabilities. It is a binary outcome and we expect the stock price to remain range bound until we get increased clarity.
Most LCDs are finalised but as time passes the odds tilt in PEB's favour
On 1 August 2022, PEB confirmed notification of Cxbladder codes in a proposal for a different approach to determine which cancer biomarker tests are eligible for reimbursement. If finalised, PEB will no longer receive reimbursement payments for its CMS tests (~80% of FY23 sales). Novitas must finalise or reject the draft LCD within a year of the announcement date (28 July 2022).
In the 206 days since PEB's comment period ended we have learnt very little about whether the proposal will go ahead or not. We have undertaken a thorough exercise by analysing all 2,013 unique LCDs that have occurred since 2010 to understand (1) the finalisation rate of proposed LCDs, and (2) the decision timeframes. We acknowledge this analysis isn't perfect given the nuanced nature of each LCD, and PEB is of the view the proposal won't go ahead, but history is ultimately our most useful indicator.
Decision outcome — the majority of LCDs are finalised: 84% of LCDs have been finalised, 13% rejected and 3% are still pending.
�������Decision timeframes — finalised LCDs are much shorter than rejected LCDs: Of all finalised LCDs, the median time to decision is 69 days. Of all rejected LCDs, the median time to decision is 182 days. By Bayesian inference, the probability reduces dramatically for those decisions that occur after 200 days — 55% finalisation rate for those over 200 days versus 92% for those under 200 days.
Breaking it down — Novitas, molecular diagnostics and National Comprehensive Cancer Network (NCCN)
To further add to our analysis we have specifically filtered for LCDs related to Novitas, molecular diagnostics, and NCCN references.
Novitas appears more stringent relative to other contractors: 93% of its LCDs have been finalised.
�������Molecular diagnostics: 74% have been finalised. Median finalisation time of 119 days and median rejection time of 221 days.
NCCN: 296 LCDs had some reference to NCCN, only PEB's current proposal specifically uses guidelines as a coverage criteria.
Thanks for posting. I hope so. Cant say I like this.
"Of these 84% have been finalised (unfavourable for PEB)."
SP of PEB all over the place lately...... no reason other than pure speculation on the outcome of the Novitas LCD.
Seems today the optimists are back in charge.
Interesting....... ANZ has been busy recently.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/410011/392697.pdf
Optimists still in charge?
Crikey, more optimism.....
https://www.nzx.com/announcements/410042
https://www.pacificedgedx.com/assets/Investor-Files/PEB-Quarterly-Investor-Update-Q4-FY23.pdf
In addition it seems we will know the fate to the Novitas proposal by end July 2023....
"Novitas put forward DL39365 (their proposal not to fund,) in July 2022, and must either finalize or withdraw it within 12 months of the date of the proposal."
All in all, it's likely the new CEO and team are making good progress..... however we need more info on mere things like income, profitability, cash drain etc., to really judge this.
Level of growth disappointing. Q4 23 increased to 8,878 tests, a 14% rise on the 7,768 tests in the prior quarter (Q3 23).
Unless they increase the number of tests significantly or increase the price dramatically then the huge cash burn will continue. And no doubt another cap raise as soon as 2025 is suggested by some. 14 percent is nothing when you consider the opportunity that they say is their . We no the market is huge so can only conclude that the market thinks the product is simply not that good. It all hinges on Novitas in my opinion.
FB seem to think longer is better for a positive Novitas decision. I think it's 50/50 and believe the share price will be decimated if the decision does not go our way.
More key appointments according to my inbox.......cynics will point to increased payroll costs.
Optimists will like this as a vote of confidence by management.
1.) Pacific Edge has promoted its VP of Medical Affairs Dr Tamer Aboushwareb into a new role as Chief Medical Officer. The appointment, which will see Dr Aboushwareb join Pacific Edge's senior leadership team, is a recognition of the early impact the Medical Affairs Team has had on Pacific Edge's market engagement in the USA.
The appointment elevates medical and clinical influence into the core of strategic decision making and recognizes the value that a strong clinical focus has on coverage, guidelines and long-term shareholder value.
Pacific Edge Chief Executive Dr Peter Meintjes said: "The Medical Affairs team, established under Tamer's leadership in June 2022, has taken the opportunity to change the narrative for biomarker utility in bladder cancer detection and patient surveillance.
"The increasing engagement with KOLs, department heads and chairs at leading institutions, or owners and partners at private practices is gaining more mindshare of physicians and clinicians than ever before. This is leading to a perception change of Pacific Edge and Cxbladder, and subsequent behavior change in the management of bladder cancer patients to increasing rely on Cxbladder."
2.) Pacific Edge today announces the appointment of Danielle Gutter as its new Vice President of Sales.
Ms Gutter joined Pacific Edge Diagnostic USA (PEDUSA) on April 10th, 2023 and will head up Pacific Edge's sales efforts for Cxbladder in the USA, leading the three regional sales teams, the virtual sales team, the national accounts team, and sales operations.
Ms Gutter brings a track record in driving growth in senior sales leadership positions across the biotechnology sector. Most recently she was Vice President of Global Sales at digital healthcare company Igentify, where she was charged with building global sales strategy, marketing, and promoting the company's first-to-market digital genetic counselling platform.
Prior to that Ms Gutter held sales leadership roles in the oncology diagnostics division at Natera, diagnostics company Centogene, and scientific equipment and services provider Thermo Fisher Scientific. At Natera she built, launched, and led Oncology Division sales teams focused on the Signatera test for circulating tumor DNA (ctDNA) and immunotherapy products and testing. At Centogene she re-built and launched the company's US sales team and grew its market share.
Interesting SP action today..... up 8.5%
Speculation ahead of next Thursday's results.
Good to see. Little volume on ASX. NZX not a lot either. Only a couple of months to wait now for Novitas decision.
Novitas must finalise or reject the draft LCD within a year of the announcement date (28 July 2022).
FB think the longer we hear nothing the better the chances of a favourable decision.
Not long to wait I guess.
What an amazing investment opportunity PEB is - I guess it filled now the pages of various discussion forums for nearly 20 years.
During this time lots of hype pumped, the CEO managed to build one or two decks form the sale of shares ... and the hope never seems to die.
It always looked like success is just around the corner.
Anyway - interesting chart ... is this the heart beat of a sleeping, or of a dying monster?
Quote from: BlackPeter on May 20, 2023, 12:03 PMWhat an amazing investment opportunity PEB is - I guess it filled now the pages of various discussion forums for nearly 20 years.
During this time lots of hype pumped, the CEO managed to build one or two decks form the sale of shares ... and the hope never seems to die.
It always looked like success is just around the corner.
Anyway - interesting chart ... is this the heart beat of a sleeping, or of a dying monster?
Good only for traders, though it was over six years waiting for the second trade. https://invst.ly/104lph
Good result..... still no update on Novitas...... but due 28 July.
https://www.nzx.com/announcements/412015
FINANCIAL AND PERFORMANCE HIGHLIGHTS:
• Annual operating revenue increases 71% to $19.6 million; total revenue increases 88% to $26.1 million lifted by a 39% rise in commercial test volumes and favorable currency movements.
• Total laboratory throughput (TLT) of Cxbladder tests increases 37% to 31,565 tests, commercial tests increase 39% to 26,691 tests; US ordering clinicians grow 46% to 1,150 at the end of Q4 23
• Net loss after tax increases to $27.0 million from $19.8 million, reflecting a 58% increase in operating expenses to $53.1 million as the company invested to drive growth.
• Pacific Edge is well funded; cash and cash equivalents and short-term deposits at $77.8 million from $93.5 million at the end of September 2022 and $105.4 million at the end of March 2022....
"Supported, however, by the advice and feedback we have received from our legal advisors, industry, academics and clinicians and following numerous representations to Novitas, we remain optimistic that Cxbladder will retain coverage," Dr Meintjes said.
"We are looking forward to the deadline on July 28 when Novitas must either finalize or withdraw the proposed Local Coverage Determination (DL 39365) and the associated Local Coverage Article (DA 59125) that cast Cxbladder's continued Medicare coverage into doubt."
Activation of the Kaiser integration is also dragging out. I would have thought "administrative processes" would have been undertaken in parallel with the technology development.
Good to see PEB 'delivering on growth strategy'
They've grown their accumulated losses to $217m
Is this years $27m loss a record year ....must be or close to it
Quote from: winner (n) on May 25, 2023, 11:59 AMGood to see PEB 'delivering on growth strategy'
They've grown their accumulated losses to $217m
Is this years $27m loss a record year ....must be or close to it
Just like XRO. Great strategy.
Craig's latest. "Costs a bit to high"
FY23 uNPAT below our bottom of the market estimates...
PEB's losses deepened further to -$33.5m in FY23, a 51% increase from pcp and 6% greater than CIPe's bottom of the market estimate (and 23% greater than consensus), due to higher than expected opex as PEB lifted headcount 33% over the period.
Although the increase in opex in FY23, particularly 2H23, will carry through to FY24, we expect the rate of opex growth to moderate in FY24. This reflects that PEB slowed headcount growth late in the year, and management also emphasized that further expansion of the team would require the achievement of key revenue and efficiency milestones such as improving tests sold per rep, or used per clinician.
Even accounting for this, we think consensus estimates for NPAT are too optimistic for FY24, and we expect PEB's loss to still increase slightly over FY24 (CIPe -$34m vs cons -$29m). We see the FY23 result and outlook as further validation of our PEB investment thesis: costs required for Cxbladder's market domination will be higher in the near term than current expectations
...but we have improved confidence in medium-term margins
Management's framework for strong revenue growth while more carefully managing costs, has led us to reevaluate our modelling of PEB's mid-term (FY27+ margins). We now think that PEB can grow these margins at low double digits, up from mid-single digits previously, more consistent with the case study of key comparator company, Genomic Health.
Key CMS coverage decision due by July
The key factor weighing on PEB's share price remains the potential loss of CMS insurance covering c.60% of their test volumes. The as-yet unfinalised proposal to remove Cxbladder's Medicare coverage is nearing its one-year filing anniversary on 28 July 2023. Should the proposal fail to be finalised in its current form (which we think is the most likely - but far from certain - outcome), PEB's shares are likely to be re-rated higher.
Maintain Neutral, target price +10% to $0.56
With significant uncertainty around the Medicare coverage decision remaining, we retain Neutral, with our target price increasing +10% to $0.56 following the margin revisions noted above
So if it continues Medicare coverage I wonder what the upside is to current share price and the downside if it fails?
It now seems the Novitas decision is much closer.....ie 9 June.....but still too early to call?
https://www.nzx.com/announcements/412459
"We understand that there is no required announcement from Novitas upon passing the expiration date."
Trying v hard not to let optimism break out!
Quote from: Left Field on Jun 02, 2023, 09:18 AMIt now seems the Novitas decision is much closer.....ie 9 June.....but still too early to call?
https://www.nzx.com/announcements/412459
Trying v hard not to let optimism break out!
Next week eh
I thought that the longer it dragged on the greater the chance of a good outcome
Good luck
A company with advisors and presidents galore and they can't get the dates right. Good news but a bit of a concern.
Quote from: Shareguy on Jun 02, 2023, 11:35 AMA company with advisors and presidents galore and they can't get the dates right. Good news but a bit of a concern.
I get the impression that PEB have no idea what they are doing ..hopeless
I'm confused ...why is this good news
Quote from: winner (n) on Jun 02, 2023, 12:01 PMI get the impression that PEB have no idea what they are doing ..hopeless
I'm confused ...why is this good news
Good news because we will no a lot earlier re Novitas. What will the share price go up to on a positive decision?
With a week to go it's looking positive.
Quote from: Shareguy on Jun 02, 2023, 01:49 PMGood news because we will no a lot earlier re Novitas. What will the share price go up to on a positive decision?
With a week to go it's looking positive.
it'll double won't it
JUSTASKPERCY won again yesterday .... 2 wins in a row .......might put the winnings on PEB fir a quick punt ....I'm on a roll so what can go wrong
Capital raise was at $1.35 in October 21. Since then sales have gone up and the company says the best is yet to come. Got to over $1.50.
According to Yahoo was $.78 on 29/7/22 which was the closing price before the Novitas bad news. The share price closed at $.44 1/8/22.
Of course the decision could still go against the company.
Will be interesting. I doubt we will no for sure till 12 June.
Not the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80
In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.
It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.
Quote from: Left Field on Jun 05, 2023, 07:18 AMNot the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80
In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.
It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.
Over there there was also mention of refunding what they had received for past tests
I not understand all this but that sounds like bad news
I've read through the CMS determination and saw no reference to refunding. Just that they lose coverage effective July 17th.
Quote from: Left Field on Jun 05, 2023, 07:18 AMNot the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80
In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.
It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.
Ouch - if this is confirmed it sounds like the beginning of the end of a 2 decades long rort to extract funds from gullible share holders.
Will be interesting to see which shares will replace the emerging void in share trader forums. I guess - sure, we have regularly some starlets shooting up and falling down, but continuing to keep the faithful invested for 2 decades without giving them any return, this clearly must count for something.
They are dual listed on the ASX which is open today
Quote from: Crackity on Jun 05, 2023, 09:55 AMThey are dual listed on the ASX which is open today
Last trade on asx a couple of weeks ago ...might be it back to life
No doubt trading halt coming while they formulate suitable wording to downplay announcement.
I contacted the company yesterday when I heard about this and have had no response. Have sent them emails in the past and had no response so not really surprised.
Quote from: Crackity on Jun 05, 2023, 09:55 AMThey are dual listed on the ASX which is open today
That raises an interesting question, does the stock get halted if it cant trade on both exchanges? Seems unfair that ASX holders can get out today, but NZX ones are trapped until tomorrow.
Edit: Answer my own question, yes it does get halted. There is an announcement and trading halt lodged on the ASX.
Expected https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02672815-2A1452985?access_token=83ff96335c2d45a094df02a206a39ff4
Reasons for trading halt:
The company has become aware that late on Friday 2 June 2023 (US time) Novitas, the Medicare Administrative Contractor with jurisdiction for the company's US laboratory, finalized the proposed Local Coverage Determination (LCD) (L39365) covering reimbursement of Cxbladder by Medicare.
The information published by Novitas (the LCD, the associated Billing and Coding Article (A59125), and the Response to Comments Article (A59417)) is voluminous, detailed and complex. Pacific Edge is currently reviewing the LCD and needs time to assess the implications of the LCD on the Company
What a crock - doesn't anyone work weekends in PEBland?
:o
Quote from: Crackity on Jun 05, 2023, 12:28 PMWhat a crock - doesn't anyone work weekends in PEBland?
:o
You dont even need to work, you can just upload the document to Chat GPT4 and then ask it what it means ;D
Quote from: KW on Jun 05, 2023, 12:34 PMYou dont even need to work, you can just upload the document to Chat GPT4 and then ask it what it means ;D
Yes I did that and it came back with one word "SELL"
The conclusion at the end of the document is telling
insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract.
Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry.
The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49
These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result.
Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers.
Now if you add to the mix
That Cxbladder does not have the endorsement of the AUA or NCCN.
They can't even convince NZ health authorities for nationwide coverage.
The highly paid CEO who replaced David Darling who is quoted as saying "huge potential" and what a great company despite not buying any shares himself.
It's a cluster
Quote from: Shareguy on Jun 05, 2023, 12:43 PMYes I did that and it came back with one word "SELL"
You should ask the clever bot where to sell?
Hard to sell in a trading halt and I assume the liquidity afterwards might be still a bit thinner than normal :) ;
For laughs, I asked Chat GPT to write PEB's press release ;D Here's what it came up with. Lets see how close it gets to the real thing.
FOR IMMEDIATE RELEASE
Subject: Pacific Edge Navigates Medicare Coverage Adjustment for Cxbladder Tests
City, State—Date—Pacific Edge Ltd, a pioneer in diagnostic and prognostic tests for enhanced detection and management of bladder cancer, today shares a critical update regarding its flagship product, Cxbladder.
From [Insert Date], changes to Medicare coverage will mean that Cxbladder tests are no longer included. This development stems from a recent revision by the Centers for Medicare and Medicaid Services (CMS), the federal agency overseeing the nation's primary healthcare programs.
While this is a significant change, Pacific Edge views it as an opportunity to deepen our dialogue with CMS and other key healthcare stakeholders. We are actively engaging with CMS to understand the rationale behind their decision and to explore potential pathways to reinstate coverage.
"Change is a catalyst for growth. We remain firm believers in the unique value and potential of our Cxbladder tests. This situation will inspire us to work even more vigorously to articulate the clinical and cost benefits of our products to insurers, healthcare providers, and patients," said [CEO/Spokesperson's Name, Position].
In the face of this challenge, Pacific Edge pledges to uphold its unwavering commitment to its customers, ensuring the delivery of superior service and care. All stakeholders will be kept informed as we navigate through this transition and work toward a resolution.
We appreciate your understanding and support during this time. This is a new chapter in our journey, and we remain resolute in our mission to enhance the care and outcomes of bladder cancer patients worldwide.
For further inquiries, please reach out to our dedicated customer service team at [Company's Contact Information].
About Pacific Edge
Pacific Edge Ltd is a New Zealand based biomedical company, leading the way in the development and commercialization of innovative diagnostic and prognostic tests for improved detection and management of bladder cancer.
Press Contact:
[Name]
[Title]
[Email]
[Phone Number]
Quote from: KW on Jun 05, 2023, 01:59 PMFor laughs, I asked Chat GPT to write PEB's press release ;D Here's what it came up with. Lets see how close it gets to the real thing.
FOR IMMEDIATE RELEASE
Subject: Pacific Edge Navigates Medicare Coverage Adjustment for Cxbladder Tests
City, State—Date—Pacific Edge Ltd, a pioneer in diagnostic and prognostic tests for enhanced detection and management of bladder cancer, today shares a critical update regarding its flagship product, Cxbladder.
From [Insert Date], changes to Medicare coverage will mean that Cxbladder tests are no longer included. This development stems from a recent revision by the Centers for Medicare and Medicaid Services (CMS), the federal agency overseeing the nation's primary healthcare programs.
While this is a significant change, Pacific Edge views it as an opportunity to deepen our dialogue with CMS and other key healthcare stakeholders. We are actively engaging with CMS to understand the rationale behind their decision and to explore potential pathways to reinstate coverage.
"Change is a catalyst for growth. We remain firm believers in the unique value and potential of our Cxbladder tests. This situation will inspire us to work even more vigorously to articulate the clinical and cost benefits of our products to insurers, healthcare providers, and patients," said [CEO/Spokesperson's Name, Position].
In the face of this challenge, Pacific Edge pledges to uphold its unwavering commitment to its customers, ensuring the delivery of superior service and care. All stakeholders will be kept informed as we navigate through this transition and work toward a resolution.
We appreciate your understanding and support during this time. This is a new chapter in our journey, and we remain resolute in our mission to enhance the care and outcomes of bladder cancer patients worldwide.
For further inquiries, please reach out to our dedicated customer service team at [Company's Contact Information].
About Pacific Edge
Pacific Edge Ltd is a New Zealand based biomedical company, leading the way in the development and commercialization of innovative diagnostic and prognostic tests for improved detection and management of bladder cancer.
Press Contact:
[Name]
[Title]
[Email]
[Phone Number]
Love it KW. I think your chat bot will be bang on the money. PEB management should maybe have utilised the chat bot to find out the correct date for the Determination (LCD).
Quote from: Shareguy on Jun 05, 2023, 03:27 PMLove it KW. I think your chat bot will be bang on the money. PEB management should maybe have utilised the chat bot to find out the correct date for the Determination (LCD).
It can also write really good CEO resignation letters ;D
Quote from: KW on Jun 05, 2023, 03:55 PMIt can also write really good CEO resignation letters ;D
Go on - give the good doctor a helping hand
FB says $0.29 Under this scenario we assume further equity raise risk is heightened.
Quote from: Shareguy on Jun 05, 2023, 05:30 PMFB says $0.29 Under this scenario we assume further equity raise risk is heightened.
As at 31 March they had 77.8 million NZD in cash and near cash. That good for a while.
What they don't have now though is a possibly viable business or real way forward?
🤔
Quote from: Shareguy on Jun 05, 2023, 12:59 PMThe conclusion at the end of the document is telling
insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract.
Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry.
The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49
These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result.
Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers.
Now if you add to the mix
That Cxbladder does not have the endorsement of the AUA or NCCN.
They can't even convince NZ health authorities for nationwide coverage.
The highly paid CEO who replaced David Darling who is quoted as saying "huge potential" and what a great company despite not buying any shares himself.
It's a cluster
The root cause of the problem is many DHB's simply don't think the test is reliable enough..
I had a bad UTI with blood in my urine about a decade ago that didn't clear up quickly with antibiotics. It was painful and deeply distressing and its easy to worry yourself sick.
I ended up in North Shore hospital getting a Cystoscopy which is not a lot of fun but while there I asked the highly experienced Oncologist why they don't use CX bladder tests. She told me there's no point as for $1,500 total approx. cost to the health system , you simply cannot beat putting a camera in there and having a really good look around. Not worth risking people's lives for that small amount of money. Far better to get a far more definitive answer by doing the procedure. She gave me a very thorough prostate examination while I was there too. What a 'wonderful bonus" that was lol You really leave your dignity at the door when you arrive, knowing what you are going to have to go through but afterwards I had this overwhelming sense of relief that she found nothing wrong and I felt very fortunate indeed to have had quick access to a free and very thorough examination by a highly experienced Oncologist
I felt 100% about 10 days later with different antibiotics and the problem has thankfully, never recurred.
Comment.
I think the number of false positives with CX Bladder is pretty shocking.
Forbar downgrading to 29 cents and suggesting that makes them a candidate for another capital raise. Hmmm When is enough, enough ? They've "milked" a lot of money out of this company over the years with all the capital raises they've promoted and supported. Is it acceptable that every so often they milk a new batch of investors for more capital?
KW - That response from Chat GPT is stunning. You'd have to pay a public relations firm many thousands of dollars to come up with a better answer than that. Off topic, but I think many of the tech experts starting to say we should be very worried about A.I., are probably right.
Watched a re-run of Terminator 2 with my granddaughter yesterday. How long before that might become real ?
Quote from: Basil on Jun 06, 2023, 09:27 AMKW - That response from Chat GPT is stunning. You'd have to pay a public relations firm many thousands of dollars to come up with a better answer than that. Off topic, but I think many of the tech experts starting to say we should be very worried about A.I., are probably right.
Watched a re-run of Terminator 2 with my granddaughter yesterday. How long before that might become real ?
The person who invents a terminator style AI guard "dog" will make a fortune. Especially in this country.
To their credit PEB came back to me this morning and said
Thank you for reaching out.
We have implemented a trading halt while we review the information and obtain opinions from experts in the US.
We will be updating the market tomorrow morning, and will also provide an opportunity for investors to dial in and listen and engage with the CEO, CFO and Chair. Details of this call will be released to the NZX and ASX during the day.
Best regards
Quote from: KW on Jun 06, 2023, 11:33 AMThe person who invents a terminator style AI guard "dog" will make a fortune. Especially in this country.
Too late, already done. https://thehill.com/changing-america/resilience/smart-cities/4018672-robot-dog-coming-to-los-angeles-police-after-vote/
How long before they give Spot defensive and then after that, attacking capabilities?
Wow NZX made a mistake and briefly allowed trading.
266k traded
Quote from: Shareguy on Jun 06, 2023, 01:42 PMWow NZX made a mistake and briefly allowed trading.
266k traded
Surely they are going to have to cancel all those contracts ?
Anyone know if PEB is currently a constituent stock in the NZX50 ?
Yes we will see. Yes number 41
Quote from: Basil on Jun 06, 2023, 01:54 PMSurely they are going to have to cancel all those contracts ?
Anyone know if PEB is currently a constituent stock in the NZX50 ?
Pretty sure it is ...lol
Good news for TRA when PEB gets kicked out of NZX50?
Much too early to tell at this stage Winner. NPH and GTK also inline for inclusion as is TRA.
SAN might get booted out for liquidity reasons and then there's WHS's and SML's price collapses in recent months in play as well for possible exclusion.
Lot of water to pass under the bridge between now and end of August...much will depend upon share price and volume action of all of the above as well as PEB.
There's a lot of moving parts.
Thanks for link Shareguy but on a really quick look it doesn't look accurate to me. E Road was booted out last year from memory and HLG is in the NZX50 but not in that list. Not sure if there are other errors.
Quote from: Shareguy on Jun 06, 2023, 02:19 PMhttps://www.interest.co.nz/nzx50
Bit out of date that list
Yes agree. Dated May 23 but clearly wrong.
Quote from: Shareguy on Jun 06, 2023, 02:55 PMYes agree. Dated May 23 but clearly wrong.
All the comments at the bottom of the story are from 2020 ...
PPH has gone as well. ....
So if we use the trading today as a guide for tomorrow.
Opened $0.495
Low. $0.275
High $0.28
Volume. 266999
Feel sorry for all the people who brought on Friday.
PEB asks NZX to halt trades, yet somehow today shares have been traded?
Off market deals?? Anyone care to explain how this can happen?
Quote from: Left Field on Jun 06, 2023, 04:25 PMPEB asks NZX to halt trades, yet somehow today shares have been traded?
Off market deals?? Anyone care to explain how this can happen?
Apparently a mistake and trades prob be reversed ....so I'm told
I was told it was a mistake and yes trades were canceled.
Thanks Winner and Shareguy for the clarification. Appreciated.
( FWIW I note the trades have now been wiped from Jarden's depth and trade details.... market price back to where it was in Fri.)
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/412643/396026.pdf
No surprises that management are wanting to try to continue to receive their salaries for as long as they possibly can...
My view. The number of false positives is absolutely ridiculous in my opinion. Based on my personal experience noted above, I wouldn't touch this with a 40ft barge pole. Far better to insert a camera up there and have a good look around. Only reason I can see not to do this would be a chronic shortage of qualified staff.
The market is not fooled by their smoke and mirrors. Looks like opening at just 5 cents down from 48 cents. Just one tenth of what it was. WOW !
P.S. Yeap, opened at 5 cents down a whopping 89.9% on last Friday.
Fair to say this is highly likely to exit the NZX50 in due course.
Saw my JUSTASKPERCY winnings sitting there and said why not so got a few at 5.4 cents ....could be a good bet eh
Wow -5c eh? No doubt about it this is a massive blow for PEB , although maybe not a fatal one unless there's contagion to other providers. If Kaiser pull stumps, then it's game over.
I had a small flutter on PEB and wish I'd sold at it's peak - looks like I'm well and truly stuck now :'(
The whole saga is really hard to figure out, given that CXBLadder was given approval for medicaid and medicare customers only three years ago. What is known now that wasn't known then? The false positives thing is a red herring in my opinion. The bio-marking sensitivity thresh-hold can be lowered or raised as far as I'm aware. Better to set the bar low and have a 100 false positives, than too high and miss a real one. And, it should be noted, CX Bladder is a first line of defence screening tool designed to weed out out those with non-threatening, small amounts of blood in the urine. Without such a tool, everybody would have to get pretty nasty invasive procedure regardless of whether it turned out to be warranted or not. No-one gets one of those procedures, gets an all clear, and then complains that they didn't find anything. It's a bit like PSA testing for prostate cancer - apparently there is a significant amount of false positives with that test, but it is still a useful tool to minimise the number of biopsies.
The SP is a write-off for another decade (sigh) but I think PEB will continue in one form or another. An appeal may be successful or the new CXBladder Detect+ may address some or all of the concerns. In the meantime the digital share certificates go in the bottom drawer :'(
Quote from: winner (n) on Jun 07, 2023, 10:34 AMSaw my JUSTASKPERCY winnings sitting there and said why not so got a few at 5.4 cents ....could be a good bet eh
Races at Matamata today so sold already ......rewarding coffee break
Quote from: winner (n) on Jun 07, 2023, 10:47 AMRaces at Matamata today so sold already ......rewarding coffee break
Probably go to 25 cents later today
To be fair LoungeLizard, the PSA tests are part of a normal blood test that everyone should get once a year so are ostensibly free, albeit funded at very small cost by the health system as part of the blood test.
What does a CX Bladder test cost ?
In terms of a cystoscopy being a 'nasty" invasive procedure, yes, its uncomfortable, but in terms of getting a definitive answer I would describe it as a real relief to be honest and there are no side effects or lingering pain that I noticed.
I agree about PSA tests - they are no brainer to have done once a year - and they are free. But if you have private medical care or in this case medicare/ medicaid then CXBladder would be free as well.
I guess my point is that CXBladder wasn't designed to replace a cystoscopy. They work in tandem - Cxbladder screens out a segment of the population who have signs of hematuria but is not serious - eg a urinary infection treatable with antibiotics. If there was no screening then everybody has to have a cystoscopy whether it was needed or warranted or not. That's bad for the patient and clogs up the medical system.
Medical Biomarking, I believe is still the way forward for many diseases. It really is hard to tell now whether PEB have a good product or not. I don't trust the US medical system - it's inefficient and there's an unhealthy relationship between providers and health authorities and hospitals themselves. This could be political all we know - the medical establishment protecting its own. It will be fascinating to see how it plays out. There could be a twist in the tale yet and maybe Winner is right - at 5c it might be worth a flutter???
Thanks LoungeLizard, I respect your point of view.
For what its worth, if I remember correctly and I am not sure I do, I think it was about $400 for the CX Bladder test about a decade ago. Whether it's worth that or just having the cystoscopy for about $1,500, (again a decade or so ago money so will be more now), is something the various DHB's appear to have differing opinions on. All I can say is I am glad I had quick access to the procedure giving a definitive answer to my condition at the time and even more glad it hasn't presented as a problem again.
The market seems to think PEB may possibly have a future but it's definitely not for me. I hope it works out for shareholders.
P.S. For what it's worth I note the company had $53m in operating expenses last year. If they are going to start issuing legal challenges, I would think that will make a separate major dent in available funds such that including legal costs they probably have somewhere around about 1 year, perhaps a little longer to make the case to shareholders why they should remain in business. If they can convince the market they have a viable road to travel going forward, this will almost certainly require yet another capital raise. Biotech companies are in my opinion, extremely risky.
Quote from: Basil on Jun 07, 2023, 11:57 AMThanks LoungeLizard, I respect your point of view.
For what its worth, if I remember correctly and I am not sure I do, I think it was about $400 for the CX Bladder test about a decade ago. Whether it's worth that or just having the cystoscopy for about $1,500, (again a decade or so ago money so will be more now), is something the various DHB's appear to have differing opinions on. All I can say is I am glad I had quick access to the procedure giving a definitive answer to my condition at the time and even more glad it hasn't presented as a problem again.
Real glad it all worked out for you Basil. Cystoscopy will always be the gold standard - just a question whether there's a profitable space for CXBladder, or other bio marking outfits, to occupy in the near future. I think there is but maybe not in the timeframe that most investors would like :-\
The market seems to think PEB may possibly have a future but it's definitely not for me. I hope it works out for shareholders.
In terms of trading yesterday the shares fell from 49.5cps the prior day to an intra-day low of 5cps, they rallied as high as 16cps before closing at 10.9cps with 25m shares trading hands .... That's just 3% of the c810m shares on issue. The carnage left PEB with a market cap of $88m at the end of the day ... broadly in line with the net cash on its Balance Sheet of $78m (albeit cash-burn is estimated at c$30m for 2H23).
Today we have bugger all traded (6.2m)which says to me that the big players are thinking there might be some life in this company yet.
Have 10 cents a share in cash.
No doubt all the executives earning the big bucks won't want to give up without a fight. Goes without saying most will have families to support so they're not going to roll over and play dead like an old Labrador, even if the company has its own form of bladder cancer in terms of the viability of their operation.
I expect a real dog and pony show over the next year as they scramble to try and build a case for survival and then another case as to why they deserve even more shareholder support in yet another capital raise. How I see it is that if people are gullible enough to keep tipping money down this black hole...
IMG_0043.jpeg
Current holders as of last Friday
Here is David Darlings last disclosure that I can find.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/391172/369462.pdf
Quote from: Shareguy on Jun 08, 2023, 05:55 PMHere is David Darlings last disclosure that I can find.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/391172/369462.pdf
Quote from: Shareguy on Jun 08, 2023, 05:55 PMHere is David Darlings last disclosure that I can find.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/391172/369462.pdf
Be very surprising if DD still hold any PEB shares.
He would still be holding some of the options but they would be worthless at current prices.
We should not begrudge him taking 'tens of hundreds of thousands of dollars' from selling the shares. He has single-handedly raised many millions of dollars to keep PEB going.
Quote from: Teitei on Jun 09, 2023, 09:07 AMBe very surprising if DD still hold any PEB shares.
He would still be holding some of the options but they would be worthless at current prices.
We should not begrudge him taking 'tens of hundreds of thousands of dollars' from selling the shares. He has single-handedly raised many millions of dollars to keep PEB going.
David got PEB to where it is today ...took a while.
Remember that venture he was leading before he joined PEB ..........Arborgen still struggling to make a buckneven though Dave left 20 years ago
Maybe an indication of where the future of PEB is heading
Quote from: Teitei on Jun 09, 2023, 09:07 AMBe very surprising if DD still hold any PEB shares.
He would still be holding some of the options but they would be worthless at current prices.
We should not begrudge him taking 'tens of hundreds of thousands of dollars' from selling the shares. He has single-handedly raised many millions of dollars to keep PEB going.
Rearrange the letters to understand the true meaning.
'David Darling' = 'Ad driving lad'
Seems appropriate for one charged vith raising vunds vrom the public?
RB
Quote from: Red Baron on Jun 09, 2023, 10:37 AMRearrange the letters to understand the true meaning.
'David Darling' = 'Ad driving lad'
Seems appropriate for one charged vith raising vunds vrom the public?
RB
D Darling also rearranges to raddling
to twist together : interweave
raddled; raddling. transitive verb. : to twist together : interweave.
He was a true master of those NZX announcements 8)
I am not sure what it is about PEB but everytime I think about it I want to go and do number two's
Craig's latest
It is worth noting that we think PEB has a strong management team and a good product and, notwithstanding Novitas' view, our view on the clinical efficacy of Cxbladder has not changed.
Medicare coverage rescinded
This week PEB announced that Medicare insurance coverage, which accounts for 77% of revenue would cease entirely from 17 July 2023. The key reason for cessation is a lack of clinical studies demonstrating that Cxbladder improves patient outcomes. In our initiation last June we highlighted deficiencies in PEB's previously published clinical studies, though we have been pleased by recent progress, with higher quality data expected over the next few years. This week's announcement is a heavy blow and we think it has set commercialisation back 4+ years (though fortunately there is no impact to revenues from Kaiser Permanente). It is worth noting that we think PEB has a strong management team and a good product and, notwithstanding Novitas' view, our view on the clinical efficacy of Cxbladder has not changed. We see this as validated by: (i) top-tier accuracy metrics and (ii) insurance coverage and rollout from Kaiser, which we note was based on comprehensive health economics studies demonstrating the economic value of Cxbladder.
Medicare coverage could be re-instated by FY26
In tandem with cash conservation measures, PEB is examining multiple strategies to fill the hole left by Medicare (see p.3). So far we think the best approach is to re-apply for Medicare coverage using data from the Strata study, due to be published in 2025, which we expect will be sufficient for Cxbladder to be included in the key NCCN guidelines (one of the two conditions for Cxbladder to recover Medicare coverage), with potential for Medicare coverage to be re-instated from late FY26. However it may take longer for PEB to provide evidence to satisfy Novitas' other concerns (p.4). On p.6-7 we model a base and bear scenario based on reinstatement in FY26 and FY28 respectively. While PEB has $78m of cash, even in our base case scenario we estimate PEB will need an additional $44m of equity by FY27.
All hope is not lost...retain Neutral
We value PEB at a blended TP of $0.17 (-69%), based on a blended average of a base case ($0.21), bear case ($0.17) and estimate of the trade sale value of the Kaiser contract ($0.14). We see some valuation support provided by at $0.10 net cash per share, although this will likely be used to fund operations over coming years. This week's dramatic fall could present an opportunity for those investors with a very high risk tolerance.
Disc. Absolute punt and maybe the 3rd mistake, but added to my position yesterday.
Quote from: Shareguy on Jun 10, 2023, 10:06 AM..
Disc. Absolute punt and maybe the 3rd mistake, but added to my position yesterday.
Who knows.
However - just considering that they have a long and consistent streak in successfully fleecing shareholders without giving anything back at any point in time ... I recon that the beagles motto "the past is the best indicator for the future" might be worthwhile to consider in this specific context.
But sure - ripples come and ripples go - and some (but not many) people make money as well in the casino without owning the bank.
I think however that the odds as well as the girls (and the guys, just to stay PC) and the bar look better in the casino, i.e. if I have the urge to gamble I would go there.
But anyway - all the best.
The thing with gambling at the Casino is, you know they take a certain margin, on a roulette wheel with one zero its 1/37 = 2.7%
How I see this, is with some companies' management, staff and directors, combined, they are taking a 100% margin and you simply cannot win.
I'm calling it, there is no way this company will EVER be profitable and that makes it univestable in my book.
Of course, the brokers will tell you otherwise...with their legal disclaimers around risk prominently presented in their reports and capital raise documents...but they would say that wouldn't they to continue their rich gravy train of regular large feeds from underwriting and placement fees.
There's no point waiting for the maggots to appear out of this corporate carcass when its clear its already dead.
Of course the brokers will try and keep it on life support with yet another capital raise...(there have been so many over the years I have lost count), for quite obvious reasons lol
Forbar already saying they need another capital raise putting their hand up yet again.., ::) ::)
Interesting to see Harbour adding more at these levels. ( Mind you it's not their money.)
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413064/396507.pdf
Punters getting despondent (and with very good reason in my opinion), driving the price down 4.4% to 8.7 cps today.
Seems like the release of PEB's FY23 AR today (and the comments contained in it) have not impressed the market, (down to another 9% to 7.7c so far today.)
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413482/396909.pdf
Quote from: Left Field on Jun 22, 2023, 12:23 PMSeems like the release of PEB's FY23 AR today (and the comments contained in it) have not impressed the market, (down to another 9% to 7.7c so far today.)
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413482/396909.pdf
They have had nearly a year's notice that the LCD coverage could be gone and the AR shows glaringly that they are totally un-prepared for the discontinuance.
Would you trust them with your money?
Quote from: Left Field on Jun 22, 2023, 12:23 PMSeems like the release of PEB's FY23 AR today (and the comments contained in it) have not impressed the market, (down to another 9% to 7.7c so far today.)
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/413482/396909.pdf
True. Seems like an over-reaction to me, and at these levels it might be worth a punt. And yes, the phrase "good money after bad" does spring to mind. I can't see how the market could have expected any more than PEB laying out its options and looking to curb spending. The Novitas decision was so unexpected and so wide-reaching they need to carefully consider which option to take.
Interesting that one of the options was
d) consider other strategic alternatives, including partnerships with other large biotech businesses with strategic interests aligned with Pacific Edge.
I wonder if they have done any groundwork on this previously, or if it's a new thing brought on by the decision?
I think there's more to come from PEB on all of this, but by God, it's testing the limits of faith and patience.
Agree, if I was the CEO of PEB I would be having discussions with the CEO of FPH for sure. FPH have considerable experience with; a.) USA medical approval processes. b.) USA Legal challenges and of course there are many other synergies eg sales force, research etc etc.
Quote from: Left Field on Jun 22, 2023, 02:51 PMAgree, if I was the CEO of PEB I would be having discussions with the CEO of FPH for sure. FPH have considerable experience with; a.) USA medical approval processes. b.) USA Legal challenges and of course there are many other synergies eg sales force, research etc etc.
Seriously - why would the CEO of a company like FPH be interested in talking with anybody at PEB? I hope he has more important things to do.
I suppose you realize as well, that both work in pretty different sections of the industry ... I'd imagine that the approval for a breathing apparatus is different to the approval of a bladder cancer test.
Quote from: BlackPeter on Jun 22, 2023, 05:53 PMSeriously - why would the CEO of a company like FPH be interested in talking with anybody at PEB? I hope he has more important things to do.
I suppose you realize as well, that both work in pretty different sections of the industry ... I'd imagine that the approval for a breathing apparatus is different to the approval of a bladder cancer test.
Stranger things have happened - FPH might just look at it as an opportunity to get exposure to a new and developing filed of medicine. And the steps required to gain regulatory approval would not be dissimilar I wouldn't have thought. But it's unlikely that FPH would step in - more likely some other outfit in the Biomarking industry or even a more mainstream US based medical company with a few million to spare. I mean, despite this setback a lot of the major regulatory and industry hurdles have already been overcome. PEB may yet live to fight another day...
If BP is saying no one would waste their time to talk to PEB as he considers PEB a right-off, then that's his call and that's fine with me.
If BP is saying NZ CEO's don't work in collegial ways to sort out common issues, then that is not my experience.
I've seen many examples of NZ CEO's working together in the face of (say) unfair regulations, export opportunities etc. NZ Trade missions are just one example.
Quote from: Left Field on Jun 22, 2023, 07:35 PMIf BP is saying no one would waste their time to talk to PEB as he considers PEB a right-off, then that's his call and that's fine with me.
If BP is saying NZ CEO's don't work in collegial ways to sort out common issues, then that is not my experience.
I've seen many examples of NZ CEO's working together in the face of (say) unfair regulations, export opportunities etc. NZ Trade missions are just one example.
LOL.
Seriously - do you have a problem to address the people you are talking to?
I am saying that I see very limited common ground for a company producing mechanical apparatuses to help patients with breathing and a company analysing biomarkers which might indicate a certain bladder cancer.
They would need to deal with completely different FDA procedures and departments.
But sure - maybe these green Martians land tomorrow in Dunedin and it turns out they have a huge need for breathing apparatuses equipped with biomarker analysis for bladder cancer. Suppose though, they would not insist on FDA approval, but as you say - stranger things might have happened before.
Quote from: Left Field on Jun 22, 2023, 02:51 PMAgree, if I was the CEO of PEB I would be having discussions with the CEO of FPH for sure. FPH have considerable experience with; a.) USA medical approval processes. b.) USA Legal challenges and of course there are many other synergies eg sales force, research etc etc.
PEB has spent tens of millions of dollars in the US on lawyers, consultants and highly paid staff to get somewhere and then, no where in recent times with the LCD withdrawal. Its advisory board over the years also had some high powered well connected individuals in the US (or so the company boasted).
Why and how would a company like FPH be able to add any value given the above?
Unless PEB is admitting that it has been using the wrong resources/advice/help in the last 10 years!
PEB fighting on.
https://www.nzx.com/announcements/414089
Pacific Edge Chief Executive Dr Peter Meintjes said: "Despite the determination by Novitas, thousands of urologists across the US and around the world share our view that Cxbladder offers clinically valuable and actionable information. This information can improve the standard of care for patients suspected of or previously affected by bladder cancer, can offer improved patient management options for physicians, and spare patients from unnecessary invasive urinary tract examinations.
"When clinicians explain to patients that a Cxbladder test may allow them to safely avoid a cystoscopy, we expect many will accept some patient responsibility for payment if their insurer declines to cover the test".
"While the impact on demand for our tests in the US is uncertain, we expect the new approach to improve collections in the event of denial from any non-contracted insurer, including Medicare and make some contribution to revenues after 17 July."
Just the start of their dog and pony show to try and keep the dollars flowing to directors and management.
Expect a real big song and dance sometime next year with yet another capital raise....so many over the last 20 years I have lost count.
Seems like they are going to make the tests 'cheaper' so can keep throughput up.
Disc: Never been able fully understand what PEB are saying .....devil is in the detail.
A stay of execution...... (Talk of legal action does wonders it would seem.)
https://www.nzx.com/announcements/414371
In an email received by Pacific Edge from our US lawyers, the US Department of Health and Human Services Associate General Counsel Janice L Hoffman said: "Details are being worked out but there is a commitment from these two MACs (same parent company) that the LCD will not proceed as is and that the LCD will go through the LCD process again with an open meeting and public comment period".
Those who bought "when there was blood on the streets" have done well.
Finally a bit of good news for long suffering PEB holders. This decision from Novitas to go through the LCD process again, is an acknowledgment that they got it badly wrong in the first place and possibly the process and decision were legally unsound. Not to mention the potential negative ramifications for the whole biotech industry.
There will be no apology coming let alone compensation for the financial damage, but at least PEB can continue their strategy instead of throwing time and resources fighting a rearguard action.
Glad I added to my position at the bottom of the sell-sell action. ;)
Interesting that the decision has not come from Novitas, but rather from US Department of Health and Human Services Associate General Counsel Janice L Hoffman.
Clearly the US Dept of Health is not happy with the Novitas process (and decision.)
Looking v good for PEB holders IMO.
Quote from: Left Field on Jul 06, 2023, 12:34 PMThose who bought "when there was blood on the streets" have done well.
Only if you sell up and https://www.youtube.com/watch?v=UDfAdHBtK_Q
Quote from: Left Field on Jul 06, 2023, 01:20 PMInteresting that the decision has not come from Novitas, but rather from US Department of Health and Human Services Associate General Counsel Janice L Hoffman.
Clearly the US Dept of Health is not happy with the Novitas process (and decision.)
Looking v good for PEB holders IMO.
Quite right - US DOH have had to intervene and I suspect they will have had some strong words for Novitas. Medicare/Aid may also be unhappy as it reflects badly on them and affects patient relationships.
There's been a big sell-down and it remains to be seen whether there will be sufficient buyer pressure to get the SP back up to where it was before the decision (50c). Might take a while, as unfortunately the whole saga has added more uncertainty in the minds of investors. In my mind there's still an opportunity at the current price, given where the price was just a month ago.
I can't see the negative Novitas decision being re-instated and no new time frame has been released.
If PEB can continue to lift operating revenue and lab throughput at the sort of rate they did in their last report - 71% and 40% respectively - then there may yet be a happy ending for PEB investors. ;D
A readable explanation for the Novitas LCD review is covered in this helpful Blog, which also helps explain where Novitas went wrong. https://www.discoveriesinhealthpolicy.com/2023/06/novitas-releases-anxiously-awaited.html
Interestingly it seems that part of the reason for the Novitas review is/was that there are a lot of shonky lab tests out there for a lot of different issues..... the blog notes; "Novitas has paid out a billion dollars in the last couple years for Tier 2 codes, at least a good part of which, to labs indicted or pled guilty in court. "
While the recent messy Novitas LCD review saga is relegated to history (albeit with scope for a possible re-examination,) the FDA is seemingly moving ahead with possible regulations to cover lab tests ( such as PEB and myriads of others.)
https://www.propublica.org/article/fda-moves-to-regulate-lab-developed-tests
Whether this is a problem for PEB, or an opportunity remains to be seen.
https://www.nzherald.co.nz/business/best-worst-nz-stocks-in-2023-so-far/BPRBWJVHKNHJRHGNJL4GBTGZWQ/?utm_source=ST&utm_medium=email&utm_campaign=ShareTrader+AM+Update+for+Saturday+8+July+2023
Swings and roundabouts - pretty much sums up PEB as an investment.
No doubt PEB has been the worst performer of the year, but then again it was the best performer in the year that they were first given Medicare/Aid coverage. If it retains coverage and it then continues to increase market penetration and revenue, then it could be on the best performer list for 2024. Two big "ifs" there!
PEB has been one of my very few "flutters" and has lived up to that name with the number of heart palpitations it has given me over the years.
Might stick to my lane in future!
Have just stepped off Alaska cruise with no internet and have a very pleasing surprise with this announcement. Now in the green . What to do?
Quote from: Shareguy on Jul 11, 2023, 08:19 AMHave just stepped off Alaska cruise with no internet and have a very pleasing surprise with this announcement. Now in the green . What to do?
Nice problem to have.
After reading all available info decided to hold...
Craigs latest say
We value PEB at a probability weighted TP of $0.26, based on a 20% probability of retaining Medicare coverage (upside case: $0.57 - our TP before coverage appeared to be lost in June), 40% probability of losing coverage and regaining it in FY26 (base case: $0.21) and 40% probability of losing coverage and regaining it in FY28 (downside case: $0.17).
Also, we see our estimate of the trade sale value of the Kaiser contract ($0.14) and net cash per share ($0.09) as providing some support.
Craigs latest
Even if lost, Medicare coverage could be re-instated by 2026
Even if Novitas finalises the withdrawal of Cxbladder insurance coverage with substantially the same requirements as those outlined last month, we think PEB's best option is to focus on regaining Medicare coverage through Novitas. Reinstatement of coverage would require PEB to achieve two things:
1. Inclusion in clinical guidelines: Novitas' previous draft policy required inclusion in NCCN (oncologist industry body) guidelines with at least a 2A evidence recommendation. PEB could apply for this designation annually every August with new evidence generated from clinical studies. Given Novitas' prior complaints, these studies would need to demonstrate clinical utility - we think PEB's best shot at this is the Strata study, with publication expected around the first calendar quarter of 2025. Cxbladder could be included in the NCCN guidelines as early as August 2025.
2. Alteration to policy test requirements: Novitas' previous draft policy stated that Cxbladder could only be used after the clinician had seen "evidence to create a suspicion of cancer", which was then defined as abnormal results from cell or tissue testing. As stated, this requirement effectively precluded the key economic and clinical use case for Cxbladder: why use PEB's test, designed to be used before or in tandem with gold standard tissue testing, when a gold standard and invasive tissue test has already effectively diagnosed a patient with bladder cancer? We think the best course would be to lobby for a change in the definition of "evidence" to include bloody urine. Most clinicians do indeed consider this to be evidence to create a suspicion of cancer, and we believe Novitas could see this perspective if PEB demonstrates good utility data in clinical trials.
As a base case we think PEB could achieve required guideline inclusion by late 2025 which could allow submission for reinstatement of coverage by the last quarter of FY26. The key swing factor which could delay resumption of Medicare coverage would be the time required to achieve point #2 above. Although demonstration of Cxbladder's clinical utility from Strata could justify this, it is possible further evidence is required which will take more time - thus as a downside case we assume PEB will achieve reinstatement of Medicare coverage in FY28.
PEB has stated that future clinical studies and guideline inclusion efforts would focus on their new Detect+ test. Detect+ is effectively able to undertake the function of both the Detect and Triage tests - that is both (i) identify patients with bladder cancer and (ii) identify patients without bladder cancer with higher accuracy than the prior generation of tests.
We have yet to find a historical example of a test which lost Medicare coverage before regaining it. However, we note that in most observed cases of coverage rescission there were clear cases of (i) fraud or (ii) a lack of accuracy. We don't think Cxbladder fits the bill here, and expect that even if Medicare coverage is lost, it can still eventually be regained, given:
Kaiser Permanente, the USA's largest integrated healthcare provider and insurer serving 12.6m patients, plans to integrate Cxbladder into their standard of care based on internal health economics testing (this data has yet to be released). Kaiser is a sophisticated insurer/healthcare provider, focused on minimisation of costs, and our interviews with company management, and their decision to insure and roll out the Cxbladder portfolio across their network gives us confidence that the health utility and economics of Cxbladder stack up and are NPV positive.
Cxbladder has strong accuracy metrics (sensitivity: 97% and specificity of 90%), similar to the gold standard cystoscopy test (sensitivity: c.100%, specificity: c.97%) and superior to the commonly used cytology test (sensitivity: c.63%, specificity: c.96%). Cytology remains under Medicare coverage - having been invented over 100 years ago, healthcare providers see it as tried and true despite its low sensitivity and high false negative rate.
Urologists like Cxbladder - in our proprietary survey of 11 urologists, 80% of those using Cxbladder said they planned to increase their usage in the next year. Although test usage per urologist has been low, 8% of the 14,000 urologists in the US ordered a Cxbladder test in the first quarter of 2023, a number which has increased consistently over the past 3 years.
I hope you enjoyed your cruise Shareguy.
I am sure management and the brokers will be very pleased this company now has some case to stay on life support for as long as possible and brokers will be thrilled if they can milk many millions more in underwriting and placement fees and hopefully find enough punters to do half a dozen more capital raisings and keep this going another 20 years. Management taking high salaries without ever having the realistic prospect of a profit. Very questionable ethics in my opinion. Don't forget this is almost certainly going to get booted out of the NZX50 in due course so plenty of downwards price pressure to come from that.
Good luck.
Quote from: Basil on Jul 12, 2023, 09:32 AMI hope you enjoyed your cruise Shareguy.
I am sure management and the brokers will be very pleased this company now has some case to stay on life support for as long as possible and brokers will be thrilled if they can milk many millions more in underwriting and placement fees and hopefully find enough punters to do half a dozen more capital raisings and keep this going another 20 years. Management taking high salaries without ever having the realistic prospect of a profit. Very questionable ethics in my opinion. Don't forget this is almost certainly going to get booted out of the NZX50 in due course so plenty of downwards price pressure to come from that.
Good luck.
Thanks Basil. Cruise was fantastic. Now enjoying Canada for a few weeks.
Your points are valid in my opinion. It's a high risk punt. At current pricing still huge upside so prepared to take the risk.
Latest shareholder update out......... (if there are any shareholders left?)
https://www.pacificedgedx.com/assets/Investor-Files/PEB-Quarterly-Investor-Update-Q1-FY24.pdf
Pacific Edge has today released its Shareholder Update showing test volumes processed in its laboratories rising to a new record in the first quarter of the 2024 financial year (Q1 24) of 9,706. The figure represents a 9% rise on the 8,877 tests in the prior quarter (Q4 23).
The volume processed in Q1 24 also represents a 38% increase on the 7,056 tests processed in the same quarter of the prior year (Q1 23). US volumes led the growth rising to 8,627 in Q1 24, a 10% increase on the 7,816 tests in Q4 23. The figure also represents a 42% increase on the 6,073 tests processed in Q1 23.
The continued growth in test volumes comes despite Novitas'2 June 2023 release of the latest iteration of the 'Genetic Testing for Oncology' Local Coverage Determination (LCD, L39365) and its subsequent stay earlier this month. The still to be finalized LCD has the potential to end Medicare coverage of Cxbladder in the US.
The number of unique ordering clinicians in the US has continued to grow through the quarter to 1,232 at the end of Q1 24, a figure that represents more than 10% of the 12,2533 actively practicing urologists in the US. The figure is, up 7% on the 1,150 ordering in Q4 23 and up 38% on the 895 clinicians who ordered tests in Q1 23.
The update contains more information on the Novitas issue.
NOVITAS SAYS: Populations of patients in Pacific Edge trials that were tested included a strong bias towards male patients of European ancestry and were not vetted in the context of Medicare patients.
WE SAY: Novitas appears not to understand the basic demographics of bladder cancer. Males are three times more likely than women to present with the disease, patients with European ancestry also have higher incidence when compared with other ethnicities and these demographics are therefore present in greater numbers in our clinical trials. Our evidence is relevant to Medicare patients since the average age of bladder cancer patients is over 70 and Medicare eligibility is for patients over the age of 65.
NOVITAS SAYS: Cxbladder delivers a high number of false positive results, and this leads to patient anxiety and distress.
WE SAY: Novitas appears to misunderstand how Cxbladder is used by clinicians. Cxbladder's proposition relies on its high Negative Predictive Value (NPV) i.e., a negative result allows urologists to reduce unnecessary tests and procedures confidently and safely in patients at a low risk of having bladder cancer but are required to be investigated by the current standard of care. In the event of a positive Cxbladder result, clinicians should continue the evaluation of the patient for any other cause of disease, including upper urinary tract assessment.
..........a much needed update IMO.
Leftie ...you got to put some cool charts in to highlight how good they are
Good to see growth BUT still a low number of tests when you consider the market.
Have noticed American TV adverts are health dominated. Drug and health companies pushing their products, all with long disclaimers.
Quote from: Shareguy on Jul 19, 2023, 02:58 AMGood to see growth BUT still a low number of tests when you consider the market.
Have noticed American TV adverts are health dominated. Drug and health companies pushing their products, all with long disclaimers.
I suppose it depends on how you look at it. You could say there's a long runway of growth ahead of PEB if it continues to increase lab through-put year-on-year. 10% of practising urologists in the US now are using CXBladder so, glass-half-full, that's reasonable market penetration given the barriers to entry, but with a huge untapped market, if momentum can be maintained. If the Novitas decision is not re-instated. I'm still cautiously optimistic that PEB can come good.
Link to today's ASM presentation info'
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415320/399180.pdf
Attended portions of the PEB ASM, some observations
- Impressed by current management team and CEO ( Chair not impressive.)
- 1stQ FY24 test numbers up 30% on PCP so BAU progressing well. CEO noted, "we have ruled out any contagion effect from the Novitas saga."
- PEB have adjusted priorities and spending, they anticipate no Cap raise needed for several years (they mentioned 4 yrs.)
- LCD uncertainty will take up to 4 yrs to resolve but as Chairman stated, "we now have revenue and time on our side."
- More technical delay's on Kaiser online system, but PEB appear confident and say Kaiser model is not effected by Novitas and is more akin to a primary care model. Kaiser v supportive of PEB.
- Share buy back considered but PEB say - "there is better value and returns for PEB if we pursue our research."
I thought it was a pretty good, honest presentation by management, although the market seems to disagree.
They didn't underplay the significance of the uncertainty around the Novitas decision, but they do seem to have a reasonable strategy and timeframe to deal with it, even if the decision goes against them. No cap raise on the horizon and revenues should continue to increase in the meantime.
I still think that the suite of products that they have - and they are introducing new ones - represents a step change in screening technology and for the life of me, I still can't get my head around the assertion by Novitas that the technology is not "medically reasonable or necessary." I'm still think that the LCD determination will, eventually, be positive. but even if it isn't they have coverage for up to a year and should have greater market penetration - and revenue - by then. I've added some more today at just over 17c.
Interesting loungelizard.
Did any one ask why the ceo, executives and board have not brought any shares themselves lately?
Quote from: Shareguy on Jul 27, 2023, 03:18 PMInteresting loungelizard.
Did any one ask why the ceo, executives and board have not brought any shares themselves lately?
No, but that's a good point. If Management believes their own spiel about the future of PEB it should put its money where its mouth is and buy a truckload.
https://www.nzx.com/announcements/415392
Quote from: Shareguy on Jul 27, 2023, 03:18 PMInteresting loungelizard.
Did any one ask why the ceo, executives and board have not brought any shares themselves lately?
Quote from: LoungeLizard on Jul 28, 2023, 07:59 AMNo, but that's a good point. If Management believes their own spiel about the future of PEB it should put its money where its mouth is and buy a truckload.
Actually the question was asked..... and answered. Best to DYOR than to rely on a forum to do it for you.
https://www.nzx.com/announcements/415392
Anyway, the whole saga continues............. PEB a very risky investment.
Quote from: Left Field on Jul 28, 2023, 09:00 AMActually the question was asked..... and answered. Best to DYOR than to rely on a forum to do it for you.
https://www.nzx.com/announcements/415392
Anyway, the whole saga continues............. PEB a very risky investment.
Ok, I don't remember the question being asked - so what was the answer?
Yep, looks like Novitas are sticking to their guns. I wouldn't expect them to have withdrawn the LCD at this point as that would be an admission that they had got it badly wrong. The consultation period is going to determine the eventual decision and PEB seem to think that they have industry support. Time will tell.
PEB was and still is, a hight risk/high reward stock.
After careful consideration sold last of my holding today. I agree there is the potential for huge upside however todays announcement strengthens the probability that may be several years if at all, to gain coverage.
Good luck to holders.
Quote from: Shareguy on Jul 28, 2023, 05:39 PMAfter careful consideration sold last of my holding today. I agree there is the potential for huge upside however todays announcement strengthens the probability that may be several years if at all, to gain coverage.
Good luck to holders.
You may well be right Shareguy - history indicates you probably are. I'm willing to see how the next 12 months plays out, but I certainly can't blame you for cutting loose. PEB is my only high risk/high reward stock and my view - flawed that it may turn out to be - is that you can have a sizeable holding without investing a lot of cash and IF it comes good, you are in for a big, big payday. Or you can lose a few thousand $'s if it turns to custard. It's the nature of the beast.
Quote from: Shareguy on Jul 27, 2023, 03:18 PMInteresting loungelizard.
Did any one ask why the ceo, executives and board have not brought any shares themselves lately?
Also interesting to note who is not selling their existing shares.
PEB Chair, not selling and instead increasing his holding to 1 Mill shares.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415747/399678.pdf
Another show of faith (or hope) by a director......
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415927/399886.pdf
Quote from: Left Field on Aug 08, 2023, 12:03 PMAnother show of faith (or hope) by a director......
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/415927/399886.pdf
Just having a punt I feel ...hoping they get lucky
Isn't that how PEB operates
Quote from: winner (n) on Aug 08, 2023, 12:18 PMJust having a punt I feel ...hoping they get lucky ....
Takes one punter to know another aye Winnie. ;D
BlackRock also taking a punt..... 5.8% holding.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/416083/400070.pdf
Bizarre, BlackRock announcements retracted.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/NZXO/416144/400132.pdf
Not good enough from NZX - very confusing for investors. Are Blackrock buying in or not - and if they are investors are required to be informed. What is the nature of this "retraction"? Was the initial announcement incorrect in substance? Not very transparent - and NZX are partly to blame.
https://www.pacificedgedx.com/news-and-events/news/2023/us-urological-societies-call-for-medicare-lcd-revision/ (https://www.pacificedgedx.com/news-and-events/news/2023/us-urological-societies-call-for-medicare-lcd-revision/)
Impressive support for PEB bodes well.
The American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.
On the leader board in early trading today.....
To read the LCD submissions from AUA etc (as per above post,) follow this link. Impressive support for PEB from key organisations..
https://www.pacificedgedx.com/investors/presentations/
Quote from: Left Field on Aug 30, 2023, 10:36 AMOn the leader board in early trading today.....
To read the LCD submissions from AUA etc (as per above post,) follow this link. Impressive support for PEB from key organisations..
https://www.pacificedgedx.com/investors/presentations/
Yes, industry support for CXBladder is very strong and it remains to be seen whether it will have any bearing on Novitas's eventually decision. If clinicians are positive (plus it saves money), then it's hard to see how Novitas can continue to maintain, independent of all the expert medical bodies, that there is no medical benefit. Will they change their minds, particularly if there is similar strong written submission support from industry is the big question.
Quote from: LoungeLizard on Aug 30, 2023, 11:11 AMYes, industry support for CXBladder is very strong and it remains to be seen whether it will have any bearing on Novitas's eventually decision. If clinicians are positive (plus it saves money), then it's hard to see how Novitas can continue to maintain, independent of all the expert medical bodies, that there is no medical benefit. Will they change their minds, particularly if there is similar strong written submission support from industry is the big question.
Pending Novitas's decision PEB remains a risky investment.
However, reading these submissions it is clear that Novitas's earlier decision contained huge errors and elements of predetermination. PEB won its first legal challenge of Novitas based on procedural issues. The predetermination element remains untested and could potentially be very costly for Novitas if their next determination is as bad as their first one.
In light of these legal issues Novitas will now have to tread very carefully and given the strong evidence now tabled showing the cost savings and other benefits of PEB's diagnostic tools, IMO the balance of a favourable outcome has swung in PEB's favour. Of course this is just one opinion, and is not intended as any advice. DYOR.
(This my last post for a few months as I take an extended break. Happy investing all.)
Quote from: Left Field on Aug 30, 2023, 03:24 PMPending Novitas's decision PEB remains a risky investment.
This 100%. All the eggs are in one basket and, looking at the company history and approval fiasco, I sense PEB is running on "Hopium".
Disclosure: never held, another morbid curiosity
PEB SP tops the leader board last week (up about 26% for the week) on the back of PEB releasing detailed submissions made on it's behalf to Novitas earlier.
https://www.pacificedgedx.com/investors/presentations/
Amongst the presentations, The American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) provide strong support for PEB's case, concluding;
".....we firmly believe the implications of the Draft LCD will detrimentally impact access to urine-based tumor markers in the context of bladder cancer, thereby compromising patient care. If urine-based tumor markers are to be included in an LCD, their coverage should be determined through appropriate use criteria widely recognized by the specialty of urology and guided by expert input and stakeholders. We implore you to reconsider the inclusion of these tests in the proposed LCD and stand ready to engage in further discussions about the merits of these tools in patient care."
They also detail cost savings achieved by using the PEB tests.....
"The cost of tumor marker testing is remarkably insignificant when considered in the context of the massive spend associated with the surveillance and treatment of bladder cancer patients. An average FISH (ie PEB) test costs less than 1% of the $55,267 median attributed cost after two years of bladder cancer treatment. A study published in the Journal of the American Medical Association Network (2020) underscored total median costs at 1 year were $29 459; at 2 years, $55 267 and at 5 years, $117 361. Patients with progressive disease had significantly higher median 5-year costs ($232 729 vs $94 879), with outpatient care, pharmacy, and surgery- related costs contributing.xi A FISH (ie PEB) test costs approximately $500."
Reading through all the submissions it seems that opposition to the proposal by Novitas has galvanised impressive stakeholder support that bodes well for PEB in the future.
PEB still running hot - Up 12% today on high volume. Does Mr. Market know something or pure speculation? Most probably the latter, but it does seem that the odds are shortening on a favourable Novitas decision.
Quote from: LoungeLizard on Sep 15, 2023, 01:39 PMPEB still running hot - Up 12% today on high volume. Does Mr. Market know something or pure speculation? Most probably the latter, but it does seem that the odds are shortening on a favourable Novitas decision.
Yeah, and on huge volume (for PEB) too. 31m is about 4% of their register. That's nearly twice their next biggest trading day in the last two years. Bit of an eyebrow raiser, eh.
Replying to 850man's message (https://www.sharetrader.co.nz/showthread.php?2705-PEB-Pacific-Edge-Ltd&p=1022391&viewfull=1#post1022391) on 'the other site' here, since I've lost the ability to post there. Hope he/she/they are viewing here too.
QuoteYes, CXBladder is seen by urologists as a key part of the diagnosis of haematuria, based on the AUA feedback to Novitas' proposed LCD. http://nzx-prod-s7fsd7f98s.s3-websit...969/402704.pdf
I have a friend, let's call him beartrap, who recently underwent screening for microscopic haematuria at a respected hospital in Southeast Asia. When it came to ruling out bladder cancer, it was cystoscopy or nothing. The urologist claimed he hadn't even heard of Cxbladder.
The cost of the two are similar, and for the doctors nothing beats getting in there and having a poke around.
(disc: just an avid spectator)
Same for this dog at North Shore hospital many years ago. The urologist had heard of CX Bladder but said you simply cannot beat the gold standard of a cystoscopy and having a good look in there. Wasn't my most fun day in recent years by any means but I'd rather have the gold standard by a urologist with decades of experience than be a lab rat for PEB's hit and miss test. Beagle's have a very special dislike for posing as a lab rat.
All your anecdotes might indicate is that the medical profession is often slow and stubborn to accept change. The fact Kaiser Permanente are in favour of CX bladder as is the AUA for me Carrie's a lot more weight than stories from a few years ago about a urologist that might've been educated in the 1970's
Quote from: Arbroath on Sep 23, 2023, 06:28 AMAll your anecdotes might indicate is that the medical profession is often slow and stubborn to accept change. The fact Kaiser Permanente are in favour of CX bladder as is the AUA for me Carrie's a lot more weight than stories from a few years ago about a urologist that might've been educated in the 1970's
By 'recently' I meant in the last few months. Prior to cystoscopy, there was a CT scan and ultrasound. The urologist had his own ultrasound machine in his office. Nothing backward about it.
The view I've formed on this so far is that urinalysis tests are best as part of routine screening. Get a checkup every year, run an array of tests, and see what comes up.
I'm not sure if Cxbladder is suitable for such use - aside from needing to scale up volume and scale down cost, would the false positive rate be too high?
As said, CXBladder isn't an either/or option to a cystoscopy - it's an accurate, cheap and painless screening tool that augments but doesn't replace the more invasive procedure. In that sense it is just similar to a standard blood test used to screen, say, PSA levels for prostate cancer. You wouldn't want to immediately get a biopsy done if you were going to the bathroom more often - you would want to get a blood test first to determine whether the PSA level is within the "normal" range. If it outside the range you go and get the gold standard invasive procedure. Same with CX Bladder. It just makes sense to screen out those who may be symptomatic but don't actually have an issue.
I'm encourage by the response of the big 3 urological associations (who cover every urologist in the US) in essentially saying that Novitas seem to have misunderstood or ignored the usefulness of CXBladder as a diagnostic tool and that by not funding it, Medicare/Aid will end up paying more through performing more cystoscopies. Unfortunately there's so much politics and skullduggery in the US health industry that it's not a given that common sense will prevail and CXbladder etc will regain coverage. Therein lies the risk. But if does then there's no reason why the SP won't immediately return to previous levels (50c). That's a big payday for people prepared to take a punt at the current SP (13c) ;D
Last I heard blood tests are quite cheap and you get a heck of a lot of information about a patient's health from one but the CX Bladder test was about $NZ400 and you get 1 bit of semi reliable information from it. PSA tests are not super reliable either which is why if you have the courage, you should ask your doctor to check the other way every now and again. That's another real "fun" experience lol
For me with PEB, they have burned through so much capital and cried wolf so many times that their existing resources will see them through to being cash flow positive, which has proved to be a lie so many times over and over now I call complete B.S. on their business model.
One final caution for punters, this is almost certain to exit the NZX50 in the December rebalance and all that index exit downward selling pressure on an illiquid stock, it isn't going to be pretty that's for sure!
yes bit of a shame this things hasnt taken off... or has it... was that it.. some brokers under water on this one?
ok your saying something is going to get in... my gosh not another HLG...like spike ... for the lucky one..
PEB and SML likely to get booted out of the NZX50 and replaced by GTX and TRA at the December rebalance.
There has been a few directors buying recently although in relatively small $ values. However the buying of 8 million shares at a cost of $1,015,200 on 15th Sep by Anatole Masfen is significant.
Quote from: Highgate on Sep 25, 2023, 10:20 AMThere has been a few directors buying recently although in relatively small $ values. However the buying of 8 million shares at a cost of $1,015,200 on 15th Sep by Anatole Masfen is significant.
Welcolme to stocktalk. I still can't get over the fact that the board have only brought small values recently as you say apart from Anatole Masfen. Gosh apart from his purchase of 8m shares at $.1269 on the 15/9/23 he also brought 1.32m at $1.35 30/9/21 ouch. The ceo not buying any is a BIG red flag for me.
Yes it is a concern. Perhaps he is happy enough with his 3m options and 386k ord shares. Interesting to see the 201k performance shares issued just prior to the close of submission phase.
Todays announcement has lots of long words and doesn't make much sense to me but I suppose it's not bad news even though market PRICE SENSITIVE
Word regulate in heading a bit of a worry though
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf
Quote from: winner (n) on Oct 02, 2023, 09:41 AMTodays announcement has lots of long words and doesn't make much sense to me but I suppose it's not bad news even though market PRICE SENSITIVE
Word regulate in heading a bit of a worry though
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf
Hard for the layman to understand it's implications but imo, apart from perhaps more compliance costs, I wouldn't think it would overly affect products like CXBladdder which have already past trials/tests and a have proven to be safe and effective.Sounds to me like its more of an attempt to bring additional control and oversight of the medical devices industry.
Must have bad news ....share price heading down again
Quote from: winner (n) on Oct 02, 2023, 10:36 AMMust have bad news ....share price heading down again
Yep, market doesn't seem to like the news. Sigh.
From the AFR
"Pacific Edge has flagged that new proposed changes to US Food and Drug Administration guidelines could result in more red tape for its bladder cancer diagnostic device, Cxbladder.
The proposed changes, if enacted, would require Pacific Edge to present evidence to the FDA that its tests were "safe and effective for their intended use" in addition to the current regulatory requirements."
The news is another nail.
From FDA announcement
The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death. For example, the FDA is aware of IVDs offered as LDTs that could have led to: patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies.
I think there are already serious questions about the efficacy of PEB's tests.
Put it this way. There's no way if I thought there was a risk to my health down there, I would bother with a PEB test, I'd get a cystoscopy straight away even if I had to go private. You don't play games with hit and miss lab tests when it comes to the risk of cancer. What's the chances of the FDA thinking the same? Pretty good I reckon. Even if the FDA do approve it, I remain unconvinced there is a business model here that will ever generate sustainable real earnings.
I'm surprised the share price is holding up. What's the share price worth if it does not get approval and insurance coverage is lost from Novitas. CEO has done very well not putting any of his cash into shares. I see Peter earned $693,000 plus bonus shares in FY23.
I guess it's a struggle in Dunedin with cost of living, let alone to buy shares in the company you lead.
Good luck to holders
Quote from: Basil on Oct 02, 2023, 02:32 PMI think there are already serious questions about the efficacy of PEB's tests.
Put it this way. There's no way if I thought there was a risk to my health down there, I would bother with a PEB test, I'd get a cystoscopy straight away even if I had to go private. You don't play games with hit and miss lab tests when it comes to the risk of cancer. What's the chances of the FDA thinking the same? Pretty good I reckon. Even if the FDA do approve it, I remain unconvinced there is a business model here that will ever generate sustainable real earnings.
I have to disagree on that one. The specificity and sensitivity of the tests are as good/better than any other normal screening method. CXBladder passed an extensive array of clinical trials and tests and has the support of all the three main Urological associations, who have also conducted their own tests. Plus an increasing number of urologists themselves are using it and they wouldn't be doing so if they didn't think it was safe and reliable.
But also, it's all very well going through a cystoscopy if you can afford it, but a lot of people, particularly in the US, can't. And quite frankly, western public health system (if their is one) simply can't afford to put everyone through the gold standard unless - and this is where the value of screening comes in - the abnormality falls outside what my Doctor used call the "normal abnormal" range.
What I can't understand is why providers like MedicAid/care are not supportive of the technology. There seems to be an almost wilful ignorance of just how medically useful a screening tool like CXBLadder. To say that it is "not medically relevant or necessary" seems utterly bonkers to me.
Read the following for added context
http://equityespresso.com.au/pacific-edge-fda-update/
Quote from: LoungeLizard on Oct 02, 2023, 03:36 PMI have to disagree on that one. The specificity and sensitivity of the tests are as good/better than any other normal screening method. CXBladder passed an extensive array of clinical trials and tests and has the support of all the three main Urological associations, who have also conducted their own tests. Plus an increasing number of urologists themselves are using it and they wouldn't be doing so if they didn't think it was safe and reliable.
But also, it's all very well going through a cystoscopy if you can afford it, but a lot of people, particularly in the US, can't. And quite frankly, western public health system (if their is one) simply can't afford to put everyone through the gold standard unless - and this is where the value of screening comes in - the abnormality falls outside what my Doctor used call the "normal abnormal" range.
What I can't understand is why providers like MedicAid/care are not supportive of the technology. There seems to be an almost wilful ignorance of just how medically useful a screening tool like CXBLadder. To say that it is "not medically relevant or necessary" seems utterly bonkers to me.
Fair points mate...I'm not convinced the accuracy is nearly good enough for me but as you say, not everyone is as fortunate to be able to afford the best of care. Regardless of one's view on its accuracy I don't see how there's ever going to be a viable business model here even if they get FDA approval in due course and it seems to me, they will run out of cash a long time before the 4-year phased FDA approval thing anyway so in effect PEB's short-medium term future hinges on whether there's another bunch of investors willing to stump up more capital. I think the uncertainly created by this further regulatory approval process won't be helpful for the chances of yet another capital raise being successful but who knows, it seems every few years there's another bunch of punters willing to speculate that PEB is one of the pathways to prosperity notwithstanding every other time they've raised capital they promised they were done and dusted. How many times can you cry "Wolf" (saying this capital raise sees us through to cash flow positive), and then there's no wolf before the vast majority of people, (which is where I am at), think you are just absolutely full of B.S.
Quote from: Basil on Oct 02, 2023, 06:08 PMFair points mate...I'm not convinced the accuracy is nearly good enough for me but as you say, not everyone is as fortunate to be able to afford the best of care. Regardless of one's view on its accuracy I don't see how there's ever going to be a viable business model here even if they get FDA approval in due course and it seems to me, they will run out of cash a long time before the 4-year phased FDA approval thing anyway so in effect PEB's short-medium term future hinges on whether there's another bunch of investors willing to stump up more capital. I think the uncertainly created by this further regulatory approval process won't be helpful for the chances of yet another capital raise being successful but who knows, it seems every few years there's another bunch of punters willing to speculate that PEB is one of the pathways to prosperity notwithstanding every other time they've raised capital they promised they were done and dusted. How many times can you cry "Wolf" (saying this capital raise sees us through to cash flow positive), and then there's no wolf before the vast majority of people, (which is where I am at), think you are just absolutely full of B.S.
Yes, I would definitely concede that PEB only appeals to the brave or foolhardy, or a combination thereof ::)
I wouldn't normally invest in this sort of high risk/high reward stock but I got in a while back, as I believed in the product and still do. Perhaps that's the takeaway message -don't let emotions affect your investment decisions!
On the plus side (is there one?) - cash at 31 March 2023 was $78m, down from $105m the previous year, so I don't see the need for a cap raise for a while, particularly given that operating revenue is still increasing despite all the headwinds (up 55% on previous year). IF the Novitas decision is reversed in the meantime (possible) and the new FDA requirements are met (likely) then there may yet be a reward for diehards and traders. But either way, it's going to be a bit of a slog :o
In Businessdesk this morning Chief executive Peter Meintjes is a pains to reaffirm that the company would continue to be a "US first focus company" rather than exploring other markets. There revenue is 96% from the US.
He sees the "headwinds" and regulatory issues as being midway through a football match. Which suggests he doesn't really understand football. Hopefully he has a better handle on navigating the FDA's proposed rule changes.
As PEB's SP languishes in the 10c range the company is quietly building its case as a viable and cheaper option in evaluating bladder cancer risk.
The video and background to a recent article published outlining the savings provided by using PEB on a screening or Triage basis while only resorting to cystoscopy when needed, can be seen here. https://www.urotoday.com/transformative-evidence/bladder-cancer-detection/videos/mediaitem/3682-the-promise-potential-and-practicality-of-cxbladder-in-modern-urologic-oncology-mark-tyson-ii.html?mtm_campaign=Tyson_SocialVideo_ID3682&fbclid=IwAR0ENrwZ3gazJKDpNROxkNwVoOq5PRmTf6EM_KRWKdteZIfKrgfS0JzF_7s
Still a long way till the expected Novitas decision in July 2024....yet encouraging to see growing support for PEB from independent and credible authorities .
some good news, not only to make CXB tests easier to order but also increased visibility. Positive to see support for CXB from KP as well, when Novitas are so dark on it https://www.nzx.com/announcements/421662 (https://www.nzx.com/announcements/421662)
Quote from: 850man on Nov 15, 2023, 09:03 AMsome good news, not only to make CXB tests easier to order but also increased visibility. Positive to see support for CXB from KP as well, when Novitas are so dark on it https://www.nzx.com/announcements/421662 (https://www.nzx.com/announcements/421662)
Long promised but still great news for holders.... onwards and upwards. Unlikely to see sub 10c again.
Dr Eugene Rhee, MD MBA, National Chair of Urology for Kaiser Permanente and
Regional Chief of Urology for The Southern California Permanente Medical
Group, said Cxbladder tests have greatly improved Kaiser Permanente's ability
to safely work up and provide surveillance to a highly vulnerable population
of patients.
"In addition, these tests have improved access to urology care. The very high
negative predictive value of the Cxbladder tests have allowed us to improve
access by safely reducing overwhelming demand for hematuria evaluation and
surveillance cystoscopy. It's proven to be a quadruple win: convenient and
preferred by our members, high quality - reliable results, adding additional
capacity for the organization, and a sustainable way to improve the wellbeing
of our healthcare teams," Dr Rhee said.
"For our members this means fewer invasive, uncomfortable, and time-consuming
cystoscopies and timely and efficient diagnosis. With the system integration
complete we are now well positioned to roll out Cxbladder tests across our
network. We are delighted with the way the Kaiser Permanente and Pacific Edge
teams have worked together and look forward to building on this relationship
in the future."
One of the biggest health providers has embedded CXBladder into its system and all the major urological institutions have come out in support of it. The wagons are really beginning to circle Novitas ;)
Quote from: LoungeLizard on Nov 15, 2023, 05:01 PMOne of the biggest health providers has embedded CXBladder into its system and all the major urological institutions have come out in support of it. The wagons are really beginning to circle Novitas ;)
On the face of it, you'd have to think the odds are increasingly stacked in PEB's favour for a positive outcome vs Novitas - but who knows with the madness that is the American medical system.
Mr Market certainly took a cautious view of today's very positive announcement.
Quote from: Pierre on Nov 15, 2023, 06:19 PMOn the face of it, you'd have to think the odds are increasingly stacked in PEB's favour for a positive outcome vs Novitas - but who knows with the madness that is the American medical system.
Mr Market certainly took a cautious view of today's very positive announcement.
Hmmmm - do you possibly have holders bias? And no disrespect intended - it's at an interesting juncture
Quote from: Crackity on Nov 15, 2023, 07:33 PMHmmmm - do you possibly have holders bias? And no disrespect intended - it's at an interesting juncture
No disrespect taken. It's hard to avoid holder's bias, but I think I did put a few qualifiers in my earlier comment.
However, when the US Urological profession openly and widely supports the use of CXB, and a major health insurer adopts it as standard practice too, then the Novitas view starts to become much less convincing. Still, the vagaries of the US health system mean there are no guarantees for PEB - or its shareholders. So it's no surprise that there was only a muted response on the market today.
I remain very cautiously optimistic, but am far from banking on success yet.
I do wonder if there is quite a bit of significance to this KP adoption. It seems they have identified there is a cost to be avoided and patient experience to be improved by the use of CXB in the diagnosis and post operative care of bladder cancer patients by avoiding unnecessary cystoscopies. The numbers they mention in the release are 25,000 cystos p.a. of which they consider 70% are unnecessary. Assuming they enforce the practice of using CXB, at minimum that suggests 17,500 additional CXB tests will be conducted p.a. As a percentage of current annual test volumes for PEB, that's a 50% increase.
This is just me reading between the lines and it doesn't address the Novitas elephant in the room but it is a real step forward in acceptance of CXB's role in bladder cancer practices.
Good for ego's but not much else? PEB bags a small award.
https://www.linkedin.com/posts/technology-investment-network_taking-out-top-spot-in-the-absolute-it-supreme-activity-7130811735736795136-Uejb
Holders hoping PEB prove how good they are at 'scaling up' very soon.
Good progress in tough times however net loss increases.....
https://www.nzx.com/announcements/422201
FINANCIAL AND PERFORMANCE HIGHLIGHTS
• Operating revenue increases 50% to $13.1 million; total revenue increases 22% to $16.6 million lifted by a 28% rise in commercial Cxbladder test volumes in the US market.
• Total laboratory throughput (TLT) of Cxbladder tests increases 22% to 18,229 tests, commercial tests increase to 15,401 tests; US ordering clinicians grow to 1,147, up 17.3% from the 978 at the end of Q2 23.
• Net loss after tax increases to $15.1 million from $10.2 million as the company had been investing to focus on top line growth. Expense growth has since been tempered through the restructure implemented in late Q2 24 that is not yet evident in operating expenditure.
• Cash and cash equivalents and short-term deposits at $62.2 million from $77.8 million at the end of March 2023.
OUTLOOK
Dr Meintjes said the finalization of the 'Genetic testing for oncology' Local Coverage Determination (DL39365) is the single biggest determinant of the company's prospects in the coming 12 months, with a decision due by 26 July 2024 (US Time).
"A non-coverage determination is likely to impact US volumes with the company considering processes that will see Medicare patients assuming responsibility for the payment for Cxbladder. Under such a scenario Pacific Edge, supported by its strong balance sheet, would continue to work towards regaining coverage within four years, with attempts made for re-coverage with every piece of new clinical evidence.
"Conversely, an affirmation of our status as covered by Medicare will be a catalyst for our US commercial operations, supported by a sales force that is now firmly focused on the Cxbladder proposition," Dr Meintjes said.
"Meanwhile, and irrespective of the Medicare outcome, we continue to expect an increase in volume from Kaiser Permanente, ex-US business serviced from our US laboratory and APAC business serviced from our New Zealand laboratory. We are continuing to work towards a national contract with Te Whatu Ora – Health New Zealand and to grow international testing volume in the medium term from our distribution agreements and growth markets in Australia, Latin America, Israel and Southeast Asia.
"We look forward to providing a further update in the New Year," Dr Meintjes said.
It's a pretty good result really, considering the effect the Novitas decision must have had on operations. The overhang from that decision is still casting a huge shadow on the SP, despite increasing throughput, revenue and positive developments with Kaiser. The market is just in a wait and see mode, except for the odd punter.
Craig's think
Pacific Edge have delivered good YoY revenue growth of 50% to $13m, but Rob Morrison was disappointed with a lack of feed-through from well signaled cost cutting in the face of what we think is an imminent loss of Medicare coverage (which pays for 75% of PEB's revenues) and cash crunch. NPAT loss grew 44% to -$15m, and annualized cash burn increased 6% to -$33m – with just $62m of cash remaining this implies 2 years of cash left at current burn.
Fbar say
Result below expectations, driven by higher than expected costs with equity raise possible.
Quote from: Shareguy on Nov 24, 2023, 01:42 PMCraig's think
Pacific Edge have delivered good YoY revenue growth of 50% to $13m, but Rob Morrison was disappointed with a lack of feed-through from well signaled cost cutting in the face of what we think is an imminent loss of Medicare coverage (which pays for 75% of PEB's revenues) and cash crunch. NPAT loss grew 44% to -$15m, and annualized cash burn increased 6% to -$33m – with just $62m of cash remaining this implies 2 years of cash left at current burn.
Fbar say
Result below expectations, driven by higher than expected costs with equity raise possible.
Not sure where Craigs get their cash burn figures and projections from:
"Cash and cash equivalents and short-term deposits at $62.2 million from $77.8 million at the end of March 2023. Pacific Edge expects the available cash to be sufficient to support the company through to regaining coverage in the event of a Medicare non-coverage determination, a process that may take up to four years."
Craigs latest says loss of Medicare coverage highly likely
Loss of Medicare coverage highly likely, recovery to take longer
Based on (i) continually negative commentary from Novitas, the entity which will decide whether Cxbladder retains Medicare coverage and (ii) a lack of significant new clinical evidence, we think loss of Medicare coverage (which pays for 60% of PEB's US tests) is more likely than when we last published in July. We expect loss to be effective from the start of FY25
Quote from: Shareguy on Nov 28, 2023, 06:16 AMCraigs latest says loss of Medicare coverage highly likely
Loss of Medicare coverage highly likely, recovery to take longer
Based on (i) continually negative commentary from Novitas, the entity which will decide whether Cxbladder retains Medicare coverage and (ii) a lack of significant new clinical evidence, we think loss of Medicare coverage (which pays for 60% of PEB's US tests) is more likely than when we last published in July. We expect loss to be effective from the start of FY25
Hard to understand, given the support from the medical profession and the savings that CXBladder can deliver, how Novitas can still maintain their position. Politics maybe. But it does sound as though PE are preparing the ground for a negative decision and then to reapply. They have, by their own projections, 4 years of cash to see through that process and in the meantime throughput and revenue is still increasing, despite everything. But hey, Craigs have been known to be wrong...
Looks like ANZ haven't been listening to Craigs.... buying approx 9 mill PEB shares.
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/422734/408687.pdf
Gosh Jarden and Harbour sold another 10m shares, only another 124 million to go. And then there is the index rebalance as out of the NZX50. Hopefully ANZ want plenty more, otherwise...
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/422976/408961.pdf
ANZ still buying.... improving their DCA...... is it conviction or desperation !?
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/423550/409619.pdf
Quote from: Left Field on Dec 14, 2023, 05:43 PMANZ still buying.... improving their DCA...... is it conviction or desperation !?
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/423550/409619.pdf
It must be conviction - they have bought another 20m shares and ANZ now holds almost 15% of PEB.They must be expecting a big payday sometime soon.
I topped up my holding too so I hope they're right.
Quote from: Pierre on Dec 18, 2023, 11:24 AMIt must be conviction - they have bought another 20m shares and ANZ now holds almost 15% of PEB.They must be expecting a big payday sometime soon.
I topped up my holding too so I hope they're right.
ANZ certainly averaging down big time.
As at March 2023 FYAR they held 5.55% of PEB's shares or 45 mill shares.
As per the latest update they now own 14.8% of PEB or 120 mill shares.
If your DCA is less than ANZ's you should be 'well positioned." lol.
Top of the leader board today (up about 9%) ....SP climbing up towards the 9c level now that ANZ has purchased its 75 mill shares at averages in the 7c region.
Some would say it just shows how institutions can manipulate things to their advantage on the NZX.
Anyone who topped up around the recent low of 7.5c mark must be pretty happy with the SP now at 11.6c. That's good business - A 50% gain in two weeks.
Very high volumes too - ANZ hoovering up shares that were dumped after PEB dropped out of the NZX50. Or are others buying? Hope it keeps going. I've been averaging down as I still think PEB have got a genuinely good product regardless of the Novitas decision at the end of July next year. It's one for the optimists though, I would concede that ;)
I have been known to occasionally bet on red on the Roulette wheel. I'm always optimistic it will come in. ;) I think PEB is pretty much a binary bet playing out in ultra slow motion, heads they do well, tails this ends in receivership, but I prefer the "cut" that Sky City take compared to the massive extraction from proceedings PEB management vacuum up. As an aside from that, at least with Roulette, if you lose, it's over with quickly, you move on, take you loss on the chin and get on with life doing something more profitable.
Quote from: LoungeLizard on Dec 29, 2023, 12:45 PMAnyone who topped up around the recent low of 7.5c mark must be pretty happy with the SP now at 11.6c. That's good business - A 50% gain in two weeks.
Very high volumes too - ANZ hoovering up shares that were dumped after PEB dropped out of the NZX50. Or are others buying? Hope it keeps going. I've been averaging down as I still think PEB have got a genuinely good product regardless of the Novitas decision at the end of July next year. It's one for the optimists though, I would concede that ;)
I'm in the optimist camp and added a third to my holding at 8 cents- my average cost is still under water though.
The current price action is interesting and helpful but we're going to need a favourable Novitas decision before there is a substantial rerating of the SP.
If that doesn't materialise (and there's a good chance it wont), then I think we're in for a long wait unless other markets for PEB solutions emerge in the meantime.
I am slightly cheered by ANZ's commitment with ~15% holding, but lots of patience and intestinal fortitude always required with PEB.
Quote from: Pierre on Dec 29, 2023, 02:03 PMI'm in the optimist camp and added a third to my holding at 8 cents- my average cost is still under water though.
The current price action is interesting and helpful but we're going to need a favourable Novitas decision before there is a substantial rerating of the SP.
If that doesn't materialise (and there's a good chance it wont), then I think we're in for a long wait unless other markets for PEB solutions emerge in the meantime.
I am slightly cheered by ANZ's commitment with ~15% holding, but lots of patience and intestinal fortitude always required with PEB.
Yep, I'm still in the red as well, and prepared for the long haul...
Still quite a bit of buying going on. Haven't seen this sort of upward pressure for a while. A general sign of confidence in PEB's future???
Long haul...?
A road too far for me.
I do like positive cash flow from operations.Saves a lot of heart ache.
Quote from: lorraina on Jan 03, 2024, 11:41 AMLong haul...?
A road too far for me.
I do like positive cash flow from operations.Saves a lot of heart ache.
PEB is in the "fun" part of my portfolio. I wont go broke if the company does, but will do very well if it succeeds. Naturally though, I'm hoping for success - and lots of fun to follow.
I suppose one gets to the point where selling up at 10 or 11 cents only crystallises losses and doesn't actually return a lot of money. Better to just dig in for the long haul.
PEB in my opinion are a well run company with a very good suite of cutting edge diagnostic products and were simply blown away by two unforeseeable events - COVID and the decision to terminate Medic/Aid coverage only three years after it was granted (and after PEB had necessarily expanded operations at considerable cost). I think they will come right, I really do. They have 3-4 years of cash to do it, so that's the "long haul" I'm referring to.
Has anyone done the sums to estimate ANZ's DCA?
Quote from: Left Field on Jan 03, 2024, 12:41 PMHas anyone done the sums to estimate ANZ's DCA?
ANZ bought ~34 million shares at 65 cents in July 2020.
They announced they hold ~120 million shares at 18 December 2023.
I havent tracked their purchases of shares bought between July 2020 and December last year but, for sake of discussion and easy calculation, let's assume:
a) The July 2020 purchase of 34 million shares was ANZs first investment in PEB.
b) the 86 million shares subsequently purchased to bring their total to 120 million were bought at an average of 10 cents each.
Based on the above assumptions:
34m @ .65 each = $22,100,000
86m @ .10 each = $ 8,600,000
Total 120m shares cost $30,700,000
DCA = ~26 cents per share.
Watch out for some heavy selling when (if) PEB SP gets to around 30 cents.
These are pretty rough and ready calculations - someone else may like to tidy up my numbers.
Thanks Pierre, appreciated...... we are not far apart in our estimates.
My own 'back of the envelope' calculations had ANZ's earlier purchase of 45 Mill at a higher DCA of .78c (possibly higher as I seem to recall they purchased some in a Cap raise around $1.20 ??)
plus the recent 75 mill at .075c to .080
My estimate for their total 120 mill is between 31c to 40c.
Like you, I hope someone has more accurate records.
Update
Suppose not too bad in the circumstances
http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/425093/411290.pdf
Test volumes dropping is to be expected given the necessary drop in sales staff. PEB scaled the organisation up when Medicare Coverage was granted, so only logical to scale things back until a final decision is made. Still in a holding pattern until then.
Some positive commentary on future CXB use in Diagnosis and Treatment of NMIBC in latest AUA / SUO Guidelines https://www.auajournals.org/doi/10.1097/JU.0000000000003846 (https://www.auajournals.org/doi/10.1097/JU.0000000000003846)
"Although the current consensus of the Panel describes a limited role for urinary biomarkers to replace cystoscopic surveillance in NMIBC, the future directions in this field hold promise. Advances in sensitivity for detection of high-grade disease in a surveillance population of high-grade NMIBC patients using the CX Bladder platform have been significant. In addition, the recent review article by Rose et al has outlined the future applications of urinary cell free DNA in both detection and molecular risk stratification of patients with NMIBC, and the Panel believes this technology holds promise for future clinical application"
The holding pattern continues with some encouraging signs.....clearly it all depends on the Novitas decision yet to come.
https://www.nzx.com/announcements/429248
Quote from: Left Field on Apr 09, 2024, 09:34 AMThe holding pattern continues with some encouraging signs.....clearly it all depends on the Novitas decision yet to come.
https://www.nzx.com/announcements/429248
Yep, they're maintaining their foothold, which all things considered, is about the best they can do.
I was underestimating PEB when I said...."the holding pattern continues"
I've just read PEB's latest update and am impressed by their new research findings, new DNA analysis, and new proposed pricing. Read it for yourself here;
https://www.pacificedgedx.com/assets/Investor-Files/PEB-Investor-Update-Q4-24.pdf#msdynmkt_trackingcontext=6716cdbc-bfd7-4fbd-b13b-a1c8858f9918
Maybe a hint of optimism?
Craig's latest
We still think PEB is likely to lose Medicare coverage in the next few months, which will reduce operating revenue by more than 50% to c.$10m in FY25. With coverage loss likely and recovery to take 4+ years, the stock is not currently investable.
Fbar Latest
Under any scenario the risk of an equity raise within the next two years is elevated.
Quote from: Shareguy on Apr 11, 2024, 12:09 PMCraig's latest
We still think PEB is likely to lose Medicare coverage in the next few months, which will reduce operating revenue by more than 50% to c.$10m in FY25. With coverage loss likely and recovery to take 4+ years, the stock is not currently investable.
Fbar Latest
Under any scenario the risk of an equity raise within the next two years is elevated.
In the 1/2 year report to 30 Sept 2023, PEB said this:
"Pacific Edge has maintained a strong balance sheet with cash and cash equivalents of $62.2 million. In the event of a Medicare non-coverage determination, the company expects the available cash to be sufficient to support the company through to regaining coverage, a process that may take up to four years, with interim coverage attempts with every piece of new clinical evidence. In the six-month period the company recorded a cash outflow of $15.6 million, reducing its reserves from the $77.8 million recorded at the end of March 2023."
Looking at their historical spend and allowing for their cost cuts, I think that sounds about right.
But it does look as though PEB have been - wisely - preparing for an unfavourable decision. PEB is/was a speculative buy at best, and for holders like myself who will all be underwater to some degree, there's no real point in selling now and crystalising losses. I still believe that they have a great product that does a lot of good for cancer sufferers, and like a few here, PEB is part of my "fun" portfolio. Precious little fun to be had at the moment I'll admit, but one lives in hope ;)
Clinical Utility of Cxbladder to Headline at AUA 2024
Dear Shareholder,
A ground-breaking study demonstrating the clinical utility of Cxbladder is to be the centrepiece of Pacific Edge's activities at the 2024 American Urological Association (AUA) Annual Meeting to be held May 3 – 6 in San Antonio, Texas.
The AUA Annual Meeting represents a unique opportunity for Pacific Edge to highlight the findings of the new STRATA study and drive the adoption of Cxbladder tests. The conference, now in its 119th year, is the largest and most influential event in the US and global urological calendar, and is expected to attract over 10,000 urologists, urologic oncologists, researchers, educators, advanced practice providers, and other healthcare professionals from across North America and around the world.
STRATA, the first ever randomized controlled trial of a urine biomarker for hematuria evaluation, demonstrates Cxbladder Triage can help clinicians to safely and more effectively risk-stratify low risk hematuria patients when compared to AUA guidelines. It provides the strongest clinical utility evidence yet for inclusion of Cxbladder products in a future update to the hematuria guidelines.
The STRATA study will be presented on the podium by Dr Yair Lotan, Professor of Urology at UT Southwestern. The presentation is scheduled during a session covering advances in bladder cancer care on the morning of the first day of the conference (Friday May 3).
STRATA will also be published in the prestigious Journal of Urology on the same day and will be promoted as "practice changing research" by the AUA and the Journal of Urology in the lead up to, during, and after the event. A link to the paper is provided below (and will only become active at the commencement of the podium presentation at 10:40am Friday May 3 CDT). A selection of published comments by key reviewers of the paper will also be made available following the event.
Referencing the clinical utility of the test, authors of the paper led by Dr Lotan, said in an abstract to the study that Cxbladder Triage "can help reduce the burden of unnecessary cystoscopies... resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact".
The study showed clinicians in the test arm of the STRATA study, who could use information generated by a Cxbladder Triage test to help them determine the intensity of a patient workup, undertook 59% fewer cystoscopies than those clinicians in the control arm of the study who could not use the information from the Cxbladder test.
With the STRATA podium presentation providing a focal point for discussion throughout the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.
This year Pacific Edge will sponsor a tabletop session during the Urological Society for American Veterans (USAV) sub-meeting. This meeting will be attended by urologists working within Veterans Affairs (VA) facilities and is of particular importance as the company progresses its DRIVE and microDRIVE studies, both focused on VA patient cohorts.
Further detail on scheduled sessions at AUA 2024:
10:40am - 10:50 AM, Friday May 3 (CDT): Podium presentation - A Multicentre Prospective Randomized Trial Comparing Cxbladder Triage to Cystoscopy in Patients with Microhematuria.
10:00am - 2:30 PM Sunday May 5 (CDT): USAV Tabletop Session (Grant Hyatt, Texas Ballroom C).
Pacific Edge's CEO, Dr. Peter Meintjes says: "The invitation to present the results of STRATA as practice changing research at AUA 2024, the world's most important meeting of urologists, reflects its first of a kind status and the potential for Cxbladder tests to redefine the standard of care. Going forward, patients presenting with microhematuria with a negative Cxbladder test, can be treated as AUA low risk, safely reducing the need for cystoscopy allowing urology teams to focus their time and clinical resources on those that need it the most, while reducing the burden of invasive testing on patients.
"STRATA provides the strongest case yet for AUA hematuria guidelines inclusion. Additionally, we will use the paper as the basis of a reconsideration request to Novitas2 regarding 'Genetic Testing for Oncology' local coverage determination (DL 39365)."
Quote from: LoungeLizard on Apr 30, 2024, 10:08 AM"STRATA provides the strongest case yet for AUA hematuria guidelines inclusion. Additionally, we will use the paper as the basis of a reconsideration request to Novitas2 regarding 'Genetic Testing for Oncology' local coverage determination (DL 39365)."
Thanks LL, I particularly liked the above emphasis. FWIW I think the chances of a favourable result of the Novitas review have increased considerably (60:40) (particularly given the US Health Departments previous admonishment of the Novitas process and strong support from the AUA.)
Yes, I'm also feeing a little more optimistic after todays announcement. All credit to PEB Management - they really have thrown the kitchen sink at this. The new trial evidence and endorsement from the AUA could maybe provide Novitas an "out" from what is increasingly looking like a bad decision to withdraw coverage. But who really knows, given the absurdities of the American health system. Still, it's a glimmer light at the end of what has been a very long, dark tunnel...
Yeah, PEB have done a great job to get this AUA recognition but Novitas seems to be a law unto themselves regardless of what the AUA say. They also have the option to take cover behind the FDA and acquiesce to coverage only for FDA approved LDTs. I don't have an update on where PEB stand with FDA future approval
To save you doing the calculation the PEB research will be presented at the AUA conference at 3:40am NZST tomorrow, Saturday. May the fourth be with PEB!
I'm keen to know the results but don't think I'll be getting up that early to find out.
Details of the latest PEB research as presented to the AUA conference 3 May.
https://www.auajournals.org/doi/10.1097/JU.0000000000003991#msdynmkt_trackingcontext=c18ad493-d72b-4e74-95ae-8130cf1ff664
Summary of conclusions (but best you read it yourself.)
"In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in 59% reduction of cystoscopy use. This clinical utility of Cxbladder Triage can reduce the burden of unnecessary cystoscopies......."
"A urinary biomarker with high sensitivity/negative predictive value (NPV) could help to safely reduce the burden of unnecessary cystoscopies in this population and potentially enrich those evaluated with patients who have cancer. Cxbladder Triage (CxbT) .... ...with a published sensitivity of 95.1% and NPV of 98.5%.6,7..........."
Pretty positive writeup. I don't think there's any doubt about the clinical utility of CXBladder. It all comes down to Novitas's interpretation of their own guidelines and whether PEB's products fit those guidelines.
The market does seem to be a bit more positive in the light of AUA's findings, but who knows what's going on behind the scenes.
Still no decision re Novitas, but healthy progress and reduced cash burn...... I'm optimistic.
https://www.nzx.com/announcements/431369
FINANCIAL AND PERFORMANCE HIGHLIGHTS
• Operating revenue increases 22% to $23.9 million; total revenue increases 12% to $29.3 million lifted by a 2% rise in commercial Cxbladder test volumes in the US market and increased collections.
• Average US Sales Price (ASP) per test increased 18% from US$519 in 2H 23 to US$613 in 2H 24 following improvements in cash collection and increased volumes from our major private payer Kaiser Permanente.
• Total laboratory throughput (TLT) of Cxbladder tests increases 3% to 32,633 tests, commercial tests increased 2% to 27,347 with the rate of growth slowing in 2H 24 as the sales team was reduced and further attrition of the team was not backfilled to preserve capital.
• Cash burn reduced in 2H 24 to $11.9 million, down 24% on 1H 24 following reorganization; use of capital tightly focused on long-term strategic imperatives. Net loss after tax increases to $29.5 million from $27.0 million.
• End of period cash and cash equivalents of $50.3 million down from $62.2 million in September 2023; a runway expected to be sufficient to support the company through to regaining coverage in the event of a Medicare non-coverage determination.
OUTLOOK
Dr Meintjes said the finalization of the Medicare coverage determination remains the biggest determinant of the company's prospects for the immediate future, with a decision due by 26 July 2024 .
"A non-coverage determination is likely to impact US volumes, but we are well prepared with plans to regain coverage and, should coverage be affirmed, rebuild the momentum in the clinical adoption of Cxbladder in the US and around the world. "In the event of a non-coverage determination, these strategies include a potential legal challenge to the determination; Medicare patients assuming responsibility for the payment of Cxbladder tests; and the continued advancement of our clinical evidence program, which will give us multiple opportunities to seek a Medicare coverage reconsideration," Dr Meintjes said.
"Meanwhile, we see several catalysts to the company accelerating the adoption of Cxbladder and driving improvements in shareholder value. In addition to a positive Medicare determination, these include the favorable pricing of Detect+ and then the launch of the test, targeted for early 2025. The publication of new clinical evidence, meanwhile, offers new opportunities for the inclusion of our tests in clinical guidelines.
Still a risky share and not for everyone.
Accumulated Losses now $246m
One day they might return a profit
Quote from: winner (n) on May 21, 2024, 08:47 AMAccumulated Losses now $246m
One day they might return a profit
In good company......check out XRO.
Still a high risk/ high return stock, but PEB have strong support from the medical boards and institutions and the clinical evidence supporting the benefits of the test is starting to look overwhelming.
Doesn't mean of course that Novitas will reverse their decision, but PEB seem to have a good pathway to re-apply and in the meantime are still increasing revenue. Happy to hold and see how this plays out.
Throughout the Novitas determination there has been some serious concerns, ie;
1.) The original decision contained lots of factual errors (eg claimed sample bias to males........ for what is primarily a male illness!? etc)
2.) The US authorities call for Novitas to restart the revue process because of concerns about the process overreach and potential bias.
3.) Strong support for PEB from AUA and recent research, evidence of cost savings etc..
On the above alone it is encouraging to see PEB considering legal action should the determination go against them. "In the event of a non-coverage determination, these strategies include a potential legal challenge to the determination."
Let's hope it doesn't come to legal action....... but good on PEB for sending warning.
For Bars Review of the result
NEUTRAL
Pacific Edge's (PEB) FY24 result had no material surprises. Net cash of ~NZ$50m was slightly ahead of our expectations. The continued improvement in revenue per billable test (helped by a solid Kaiser contribution) was a small positive which offset slightly higher opex. We retain our NEUTRAL rating given the LCD outcome is binary and therefore high-risk, lab throughput is subdued, and under any scenario the risk of an equity raise within the next two years is elevated.
What's changed?
Earnings: FY25/FY26/FY27 EBITDA +NZ$0.7m/+NZ$3.0m/+NZ$1.6m with lower revenue offset by lower costs.
Target price: Increased to NZ$0.12 from NZ$0.11 given the modest earnings upgrades.
Pricing growth a positive in 2H24
A positive surprise was the continued strength in revenue per billable test, up +18% in 2H24 versus 2H23 and +6% sequentially. The two drivers are: (1) improved Kaiser performance — we estimate FY24 Kaiser revenue more than doubled versus FY23 to ~NZ$3.5m, and (2) an increase in proportion of tests paid for outside of CMS and Kaiser. At FY24 we estimate PEB's Southern California Kaiser population penetration is 0.05% (Southern California is ~37% of Kaiser's population) versus NZ at 0.08%. PEB's commentary suggested all 15 Kaiser Southern California sites volumes are increasing steadily, albeit it was conservative on the roll-out speed into other jurisdictions near term. Northern California is the likely next step, where its share of Kaiser's population is only modestly below Southern California. We had been sceptical of the patient pay strategy but early signs are positive, and we take comfort that the pricing uptick provides some insulation against the possible loss of CMS revenue (CMS was ~NZ$17m of revenue in FY24).
Solid opex control in 2H24
2H24 opex declined -NZ$4.8m sequentially to NZ$27.0m, with sales & marketing declining -NZ$3.0m, and G&A -NZ$2.4m. While this was less than we expected, PEB continues to accelerate the clinical research development which is the right strategy. For the time being, we see the 2H24 opex run rate as an appropriate base, but note PEB has levers to pull should the LCD decision require it.
Asymmetric upsides in the event of a favourable LCD outcome, but the uncertainty is very high
There were no new updates on the LCD decision which is due before 26 July 2024. PEB currently trades on ~1x EV/12 month forward sales. On a EV/sales multiple basis broadly consistent with biotech peers (5–6x), should the LCD decision be favourable, we derive a ~NZ25-30cps price. More comparable genomic peers, which have meaningfully lower revenue growth trade on ~3.2x EV/sales. Our discounted cash flow valuation scenario that assumes CMS coverage continues is NZ$0.24. We acknowledge PEB was trading between NZ$0.40 and NZ$0.50 prior to the recent unfavourable decision, but given the net cash deterioration and soft lab throughput trends, the share price may not recover to these levels (at least in the near term).
Earnings changes
We make minor earnings changes across our forecast horizon. We again downgrade our revenue expectations with lower CMS and 'other US' volumes slightly offset by higher Kaiser volumes and stronger pricing (combination of stronger Kaiser volumes and a higher share of US volumes, ex CMS and Kaiser paid for).
Our presented forecasts use our scenario that CMS coverage remains.
Our target price increases to NZ$0.12 (from NZ$0.11) reflecting the modest earnings upgrades. Our target price methodology is a probability weighted DCF scenario of: (1) no change to CMS coverage (PEB continues to be covered), (2) coverage resumes in FY27, and (3) coverage resumes in FY29. We acknowledge a tail risk that coverage isn't achieved at all, but we see this as very unlikely. Our valuation scenario that assumes CMS coverage continues is NZ$0.24.
Waiting..... waiting........ holding on....... holding on....
July newsletter in the meantime.
https://api.nzx.com/public/announcement/434271/attachment/422452/434271-422452.pdf
Not long now to the Novitas decision, and I don't think anyone has a clue as to which way it will go. I'm getting a bottle of champagne in to celebrate or drown my sorrows with on the 26th :)
Quote from: Left Field on Jul 10, 2024, 12:10 PMWaiting..... waiting........ holding on....... holding on....
It's a bit agonising isn't it. I'm hoping for the best but I'm really expecting a negative outcome from Novitas this month.
If that's the case, it's gonna be quite a grind for PEB for a year or three, but I'm confident they will succeed eventually.
Patience, young grasshopper. Trouble is I'm an old grasshopper now!
Its a little hard to read as the CMS website is not displaying correctly for me, but I think the proposed LCD now has a 'retirement date'. I assume this means it won't continue?
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39667&ver=9#lblRetirementDateSubheader
Quote from: Magic78 on Jul 20, 2024, 11:35 AMIts a little hard to read as the CMS website is not displaying correctly for me, but I think the proposed LCD now has a 'retirement date'. I assume this means it won't continue?
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39667&ver=9#lblRetirementDateSubheader
Indeed it is hard to read or understand the context of your first post....I suspect you are looking at an old report as it seemingly repeats now discredited claims, eg male sample bias ( perhaps OK because it's primarily a male issue) etc etc???
Best to wait for the official word in a more readable/reputable format.
As I understand it, Friday 26 July is the final date for news of the Novitas decision. We will probably have to wait till Monday 29 for an announcement from PEB though, with the US running the best part of a day behind us.
I think that a negative outcome is highly likely and is largely factored into the current SP. However, there might be some good buying opportunities for the patient investor if the market overreacts, as it usually does, to bad news.
Conversely, it will be fascinating to see how far the SP might rise, if we get a better than anticipated result.
Fingers crossed and GLTAH. Interesting days ahead!
Quote from: Pierre on Jul 21, 2024, 04:50 PMAs I understand it, Friday 26 July is the final date for news of the Novitas decision. We will probably have to wait till Monday 29 for an announcement from PEB though, with the US running the best part of a day behind us.
I think that a negative outcome is highly likely and is largely factored into the current SP. However, there might be some good buying opportunities for the patient investor if the market overreacts, as it usually does, to bad news.
Conversely, it will be fascinating to see how far the SP might rise, if we get a better than anticipated result.
Fingers crossed and GLTAH. Interesting days ahead!
Interesting days ahead indeed!
I hold far more than is sensible but like you Pierre, I'm not convinced Novitas will come to the party. But by God, there will be a party if they do!
It really is hard to judge what is going on behind the scenes. You could argue it both ways that the absence of a decision before the deadline could either mean Novitas are holding firm with the original decision
or they have been allowing PEB to strengthen their position, so they can say that "things have changed" and continue inclusion. Or maybe there will be a fudge and inclusion will be rolled over for another year, to allow for the FDA to get involved.
But in the end, no-one knows. Logically, the bio-marking technology that PEB employ is a win-win-win for patients, urologists and insurance providers and it should be a no-brainer for all providers to embrace it. But the politics of the US health industry seems to defy both industry experts and the evidence, and really casts a long shadow over investor confidence.
Oh well, not long now. I remain eternally optimistic that no matter what happens, eventually sense will prevail and PEB will have the last laugh. Just hope it's sooner, rather than later!
With the excitement of OCA and WHS today it's looking like it's going to be PEB's turn later in week with a 100% gain ...the stars are aligning
Quote from: winner (n) on Jul 22, 2024, 07:30 PMWith the excitement of OCA and WHS today it's looking like it's going to be PEB's turn later in week with a 100% gain ...the stars are aligning
I tell you what Winner, if PEB"S coverage is re-instated we will be looking more like a 200% gain in short order, and after that who knows?
PEB were tracking around $1.50 before the Novitas decision and there was a real buzz about its growth prospects. Could it, over time, get back to those levels if they win this battle and maybe start getting other providers on board?
Medicare Coverage Determination Still Under Review
26/07/2024, 09:42 NZST, GENERAL
MEDICARE COVERAGE DETERMINATION STILL UNDER REVIEW
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge's US lab remains in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding the Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL 39365).
Pacific Edge expected the finalization of the LCD overnight, i.e. within 365 days of initial posting. The company reached out to Novitas for comment overnight and was notified that: "[Novitas] is currently in discussion with the Centers for Medicare & Medicaid Services (CMS) regarding this proposed LCD. A timeframe for finalization is not available at this time. Please continue to watch our website for any future updates."
The continued deliberation on the LCD means that Pacific Edge's tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates and subject to medical necessity guidelines.
Pacific Edge continues to expect Novitas to finalize the LCD, but the timeframe is unknown. Pacific Edge will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution. Pacific Edge will not be making further comment on the matter until then.
----------------------------------------------------------------------------------------------
Wow - they've had a whole year to decide and it's still under discussion? I read this as very good news though as it looks as though Novitas are trying to find a way of moderating the initial decision. They would have said no outright otherwise. Wonder how the market will see it?
No decision better than a bad decision..
Looking more positive IMHO.
( I suspect the delay is Novitas being very careful about possible legal action....however I hope this never comes to a legal dispute.)
Novitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150
No timeframe provided.
Also discussed on this blog https://www.discoveriesinhealthpolicy.com/
Quote from: Magic78 on Jul 27, 2024, 08:35 AMNovitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150
No timeframe provided.
Also discussed on this blog https://www.discoveriesinhealthpolicy.com/
Thanks for posting. I will take this as a positive development for mine.
Quote from: Magic78 on Jul 27, 2024, 08:35 AMNovitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150
No timeframe provided.
Also discussed on this blog https://www.discoveriesinhealthpolicy.com/
PEB and the AUA both submitted responses on the LCD to Novitas in September 2023. It's now July 2024 - Novitas must be staffed with very slow readers, or very slow thinkers.
On the other channel Snigmac makes the following observation which aligns with my thoughts....
"An indefinite extension outside what is allowed puts both CMS and Novitas at risk of procedural unfairness and risk of litigation (from several companies). This second point could be potentially very powerful for the companies as it is incredibly unfair for CMS and Novitas to subject PEB, the other companies and Medicare users to so much uncertainty for a unstated period of time."
After the first flawed decision USA authorities stepped in and told Novitas to re-do their arguably unfair process......this latest extension only adds to the previous alleged procedural unfairness.
I'm optimistic that this will work out favourably for PEB (and hope PEB doesn't have to take the litigation option.)
While Novitas look somewhat incompetent in that this is their 2nd swing at canceling the funding of biomarker tests and even with another year to get it right, they have failed. I think this is a positive sign for PEB. Novitas could have just confirmed the LCD on Friday and ended funding but they chose to request this extension which feels to me like they may end up doing other than just confirming the LCD in the end. Let's hope this extension doesn't drag on too long and results in a favorable outcome for PEB especially following the results of the STRATA study which IMHO highly supportive of CXB as a means to reduce unnecessary cystoscopies.
Disc: holding more than feels sensible right now
Novitas not exactly covering themselves in glory here. Botched the first decision, told to try again and now still unable to reach a conclusion. Very prejudicial to PEB and opens Novitas up to a legal challenge. Like others, I'm feeling a bit more positive that ultimately Novitas might find some way to withdraw the LCD, as clearly the whole industry supports the PEB position. The delay isn't good for investors though and the SP will stay in the doldrums until a decision is made.
NOVITAS CONFIRMS MEDICARE COVERAGE REVIEW EXTENSION
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge's US lab, has confirmed that it has been granted an extension to finalize or withdraw the Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL 39365).
In a post on its website on Friday (Saturday morning NZDT), the MAC noted: "Novitas is considering all the feedback from interested parties regarding the Genetic Testing for Oncology LCD. An extension has been granted by the [Centers for Medicare & Medicaid Services ] in order for all comments to be considered thoroughly. Future updates will be published to this website and the Medicare Coverage Database."
Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting.
The continued deliberation on the LCD means that Pacific Edge's tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates, subject to medical necessity guidelines.
Pacific Edge continues to expect Novitas to finalize the LCD, but the timeframe is unknown. It will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution, but will not be making further comment on the matter until then.
--------------------------------------------------------------------
No news is good news??
Hey Leftie ...you left off you GLH :) 8) :-X >:( ;D
From the last investor update:
'Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.'
As per https://docs.google.com/spreadsheets/d/1gjxwx0ZAn8hzJcRRLfUwshiRAJ8RKwoX/edit?gid=667456751#gid=667456751
The CMS advisory panel has voted CxBladder Detect+ (0420U) to be 'gapfill' rather than 'crosswalk', so could be 12 months before pricing is confirmed.
The case for PEB CxBladder keeps getting stronger......hard for the US authorities to ignore this unprecedented endorsement.
Market seems to like it so far today.
(from email to PEB shareholders)
Dear Shareholder,
Pacific Edge welcomes an editorial in the American Urological Association's Journal of Urology supporting the use of Cxbladder to reduce unnecessary cystoscopies on patients at risk of bladder cancer.
Published in the September issue2, the editorial - entitled 'What Is the Future of Cystoscopy for Detecting Urothelial Carcinoma?' – focuses heavily on evidence pointing to the clinical value of Cxbladder in helping clinicians to evaluate patients both presenting with hematuria and those under surveillance for bladder cancer recurrence, specifically citing the recent STRATA3 study that demonstrated the clinical utility of Cxbladder Triage.
The editorial notes: "Although these novel biomarker studies raise important questions about evaluating patients at risk for UCB4, these tests have the potential to improve the management of our patients with suspected UCB who would otherwise require an invasive procedure for diagnosis. This also holds true for nonmuscle-invasive bladder cancer patients who require cystoscopic surveillance."
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are delighted to see our Cxbladder test recognized in the Journal of Urology editorial. Such supportive commentary on our recent clinical evidence in such an influential urology journal shows how leading urologists are coming to understand the clinical value of our tests in hematuria evaluation and monitoring patients for the recurrence of bladder cancer.
"It reinforces both our first-mover advantage in the commercialization of urine biomarkers of bladder cancer and the importance of clinical utility studies in updating the standard of care. It also provides further validation of our investment in medical affairs to educate the urological community on the value of our tests and our investment into our clinical research program, which we have configured to deliver the end points required for coverage decisions and guideline inclusion. We expect this editorial to build further momentum in the adoption of Cxbladder."
Authored by Journal of Urology Assistant Editor Christopher Anderson, the editorial first critiques the AUA's guidelines for the evaluation of asymptomatic microscopic hematuria, which it says results in urologists performing many unnecessary cystoscopies and missing opportunities to evaluate at-risk patients.
It then focuses on the clinical evidence to overcome these limitations, regularly referencing Pacific Edge's STRATA study, which was published in the May edition of the Journal of Urology. The study showed clinicians undertook 59% fewer cystoscopies if they were able to use the information generated by a Cxbladder Triage test. The editorial also notes the potential cost savings that come from reducing unnecessary procedures using non-invasive urine-based biomarkers such as Cxbladder.
The editorial concludes by acknowledging the continued need for cystoscopy in bladder cancer diagnosis but underscores the importance of reducing negative cystoscopies.
"If these biomarkers are employed in the first-line setting, it may ultimately improve appropriate hematuria referrals to urology and avoid the referral delays that some hematuria patients face... we are challenged to understand these tests, educate patients about them, and determine how to best incorporate them into our practice."
PEB progress in Asia
Pacific Edge today announces its medical presence at the UAA Congress to be held in Bali this week (September 5-8), which has attracted a record attendance of more than 2800 urologists.
Pacific Edge CEO, Dr Peter Meintjes will present the clinical utility evidence from the STRATA study to an APAC audience for the first time. STRATA is the first randomly controlled trial of a urine-based biomarker for hematuria evaluation ever completed. It demonstrated that presenting clinicians with a Cxbladder Triage result led to a 59% reduction in cystoscopies, the primary endpoint of the study.
Supporting Pacific Edge's presence at the meeting are independent presentations by Dr Arjun Guduguntla of Northern Health in Melbourne who will be presenting on Proposed novel surveillance schedule using Cxbladder Monitor for patients on annual bladder surveillance and Dr Prasanth Anton Sagayanathan from Sunshine Coast University Hospital who will be presenting on Clinical utility of Cxbladder in detecting bladder cancer in a far north Queensland (Australia) population.
Pacific Edge Chief Executive Dr Peter Meintjes said: "It is outstanding to see our long-standing customer and clinical study partners in Australia sharing their experience of Cxbladder with the broader community in the Asia Pacific region. Real world evidence is the ideal complement to the clinical utility evidence generated from our core evidence generation program and the UAA Congress provides a great platform to communicate this evidence to APAC urologists."
Prior to the activities at the UAA Congress Dr Meintjes visited Malaysia for a ceremonial signing of an already-signed distribution agreement with Premier Integrated Labs supported by New Zealand Trade and Enterprise and attended by the Prime Minister, the Right Honourable Christopher Luxon at the Shangri-La hotel in Kuala Lumpur. Premier Integration Labs is the sole supplier of laboratory services to IHH Healthcare – that includes the three largest individual hospitals in Malaysia3.
Pacific Edge Chief Executive Dr Peter Meintjes said: "This partnership represents a further advance in our strategy to expand the availability of Cxbladder and improve patient lives across key international markets.
You have to hand it PEB management - they have done as a good a job as they could have to make Novitas reconsider what clearly seems to be bad, unfounded decision to remove coverage. Speaking of Novitas - how much longer do they need to finalise the LCD? There's not even a timeline for an eventual decision now. Bad for the PEB, the industry, investors and patients.
Quote from: LoungeLizard on Sep 03, 2024, 04:20 PMYou have to hand it PEB management - they have done as a good a job .......
PACIFIC EDGE CHAIRMAN DELAYS RETIREMENT
DUNEDIN, New Zealand - Cancer diagnostics company Pacific Edge (NZX, ASX:
PEB) today announces Chris Gallaher has accepted a Board request to delay his
planned retirement, originally set for the end of this year after a handover
to a successor.
The Board has asked Mr Gallaher to remain as Chair into 2025 to provide
stability and confidence to Pacific Edge and its stakeholders amid the
continued uncertainty over the Medicare coverage status for the company's
Cxbladder tests and the ongoing process to recruit his successor.
In July Novitas, the Medicare Administrative Contractor (MAC) with
responsibility for Pacific Edge's US lab, confirmed that it had been granted
an extension beyond the normal statutory timeline to finalize or withdraw the
draft Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL
39365).
Mr Gallaher said: "As I signaled in our annual report in June, the Board
expects the process to recruit my successor to ramp up after the Novitas
determination. Consequently, the Board believes that delaying my retirement
at least until the LCD is finalised will enable us to make a smooth handover
to the new Chair, which is in the best interests of the company and all its
stakeholders. I am happy to provide this continuity."Good move.
Any thoughts on what this might mean for PEB? https://www.discoveriesinhealthpolicy.com/2024/09/novitas-no-lcd-but-documents-required.html?m=1
Quote from: Magic78 on Sep 09, 2024, 02:04 PMAny thoughts on what this might mean for PEB? https://www.discoveriesinhealthpolicy.com/2024/09/novitas-no-lcd-but-documents-required.html?m=1
Well spotted.
Really hard to tell what it all means, given Novitas and the US Health industry in general seem to work in mysterious ways :-\
My initial take, without more detail, would be that this could just be Novitas keeping things in a holding pattern. They obviously seem reluctant to make an actual binding decision on the LCD, perhaps pending the FDA getting involved in regulating laboratory tests. So maybe this is just them tightening up the documentation side - crossing the t's and dotting the i's. I suppose the positive spin is that PEB will continue to get coverage for the foreseeable future, but on the negative side there's still the on-going uncertainty. Probably a neutral event then?
Yes well spotted, thanks Magic.
I think this is just an administration matter to improve accountability and will have little effect on legitimate science backed operators like PEB.
USA authorities were caught by the Theranos Elizabeth Holmes case and many of the subsequent changes should be seen in this light.
https://edition.cnn.com/2022/11/18/tech/elizabeth-holmes-theranos-sentencing/index.html
Quote from: Left Field on Sep 09, 2024, 02:28 PMYes well spotted, thanks Magic.
I think this is just an administration matter to improve accountability and will have little effect on legitimate science backed operators like PEB.
USA authorities were caught by the Theranos Elizabeth Holmes case and many of the subsequent changes should be seen in this light.
https://edition.cnn.com/2022/11/18/tech/elizabeth-holmes-theranos-sentencing/index.html
I had forgotten about her and that whole episode. Once bitten twice shy for the regulators perhaps.
An update and further delay....... however reimbursement continues...
https://www.nzx.com/announcements/437962
Pacific Edge also notes the Centers for Medicare & Medicaid Services (CMS) has indicated - through a meeting with stakeholders that included The Coalition for 21st Century Medicine (C21) - that it had agreed to an extension to deliberations on the draft Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL 39365) to ensure Pacific Edge's Medicare Administrative Contractor, Novitas, had time to respond to a large volume of detailed comments and because the LCD raises unique issues. Novitas confirmed it had been granted an extension to finalize, retire or start over on the draft LCD in late July.
Given these developments Pacific Edge does not expect these matters to be resolved ahead of the company's Annual Shareholder Meeting (ASM) in Auckland on 24 September 2024, which contrasts to the previous expectations communicated in Pacific Edge's Q1 24 investor update released to the NZX and ASX on 10 July
2024.......
.......Despite the deliberations over the draft LCD, Pacific Edge continues to receive reimbursement for tests performed for Medicare and Medicaid patients – as it has without interruption since July 2020 including more than two years since the draft LCD was first published. In the event of a total or partial non-coverage determination, reimbursement will continue until at least 45 days after the LCD is publicly notified.
In the Q1 24 investor update Pacific Edge also noted CMS could make a pricing decision on the company's Cxbladder Detect+ test before the ASM on September 24. That remains a possibility
Another essentially neutral announcement which doesn't change things as they stand. Could be significant though if the AUA does favourably (for PEB) amend their guidelines:
"The review of the AUA microhematuria guideline, which was last amended 2020, is potentially significant as guidelines play a substantial role in medical reimbursement policy for Medicare and all other payers. They also have a significant influence over the practices of individual urologists."
Quote from: LoungeLizard on Sep 13, 2024, 11:02 AMAnother essentially neutral announcement which doesn't change things as they stand. Could be significant though if the AUA does favourably (for PEB) amend their guidelines:
"The review of the AUA microhematuria guideline, which was last amended 2020, is potentially significant as guidelines play a substantial role in medical reimbursement policy for Medicare and all other payers. They also have a significant influence over the practices of individual urologists."
Cause for cautious optimism IMHO. Why would AUA be reviewing guidelines if they weren't looking to update them in line with new initiatives and procedures - including potentially CxBladder?
In the meantime, the dollars continue to come in for PEB.
Quote from: Pierre on Sep 13, 2024, 11:12 AMCause for cautious optimism IMHO. Why would AUA be reviewing guidelines if they weren't looking to update them in line with new initiatives and procedures - including potentially CxBladder?
In the meantime, the dollars continue to come in for PEB.
Market seems to agree with your cautious optimism Pierre.....closed at $0.109 today up 5.8%
Craigs today
PEB – STOP PRESS - Cxbladder is likely to see a better recommendation in key medical guidelines, to be released sometime within the c.3-12 months (with a greater chance of being sooner rather than later), although exactly how much better is unclear. If the new recommendation is positive enough, it could (i) reduce the chances of Medicare coverage loss, or (ii) in the event Medicare coverage is lost, help Cxbladder win it back faster.
Quote from: Left Field on Sep 13, 2024, 05:05 PMMarket seems to agree with your cautious optimism Pierre.....closed at $0.109 today up 5.8%
The cautious optimism continues - SP up to 11.4 at 10:27 this morning.
Quote from: Pierre on Sep 16, 2024, 10:28 AMThe cautious optimism continues - SP up to 11.4 at 10:27 this morning.
Yes, it does seem that of all the recent announcements the review of the AUA'S guidelines seems to have had the biggest effect. If they can fast-track that process, we may see some good news before xmas??
SP hasn't been over 12c for a while...
Seems like some are joining the dots in the process to come. A favourable outcome from the AUA may lead to a reversal of the Novita decision and an assured revenue stream from Medicaid/Medicare. And also more urologists and providers might get on board. That would lead to a serious re-rating of PEB as a business - literally a game changer. Or more accurately a game-re-instater, as PEB were $1.50 stock before it all hit the fan.
PEB are still a high risk stock, but the increasing possibility of the above happening is drawing the punters in ;D
Quote from: LoungeLizard on Sep 16, 2024, 02:00 PMSP hasn't been over 12c for a while...
Seems like some are joining the dots in the process to come. A favourable outcome from the AUA may lead to a reversal of the Novita decision and an assured revenue stream from Medicaid/Medicare. And also more urologists and providers might get on board. That would lead to a serious re-rating of PEB as a business - literally a game changer. Or more accurately a game-re-instater, as PEB were $1.50 stock before it all hit the fan.
PEB are still a high risk stock, but the increasing possibility of the above happening is drawing the punters in ;D
PEB closed at 13c today. Plenty of optimism and not too much caution today - let's hope it's well-founded!
There's a way to go before there's any resolution, but it's great to see some interest coming back into this highly speculative situation.
It will be fascinating to see how far the SP moves should CxB be included in the AUA guidelines and if CMS coverage is retained. I will not be upset if it returns to around $1.50.
Are we finally seeing the light at the end of the tunnel?
Over 14c now and something like a 30% gain on the back of the AUA announcement.
Could all be premature but I'm starting to wonder whether the discussions between Novitas, PEB and the AUA has resulted in some sort of behind the scenes agreement that if the AUA update their guidelines based on the new studies - STRATA in particular - then this will allow Novitas to reverse their decision without a loss of face? All speculation of course, but the continued delay in the final decision could maybe indicate that Novitas were giving PEB and the AUA time to get all their ducks in a row.
Anyway, some good cheer for long suffering holders.
disc. a long suffering holder.
Hmmm...pushing on to 15c ;D
Quote from: LoungeLizard on Sep 17, 2024, 04:19 PMHmmm...pushing on to 15c ;D
Yep. Cautious optimism now converted to positive enthusiasm.
Just hope it doesn't all end in tears!
ASM this time next week..... all will be revealed.
Will the enthusiasm be justified?
Fingers crossed...... but (call me old fashioned)..... I'm still very cautious.
Quote from: Left Field on Sep 17, 2024, 09:08 PMASM this time next week..... all will be revealed.
Will the enthusiasm be justified?
Fingers crossed...... but (call me old fashioned)..... I'm still very cautious.
Right now, caution is completely rational and totally justified. There is absolutely no certainty about any of the potential outcomes from what's going on in the US.
I very much doubt anything will be revealed at the ASM on the 24th.
Here's what PEB said in their 13 September announcement:
"Given these developments, Pacific Edge does not expect these matters to be resolved
ahead of the company's Annual Shareholder Meeting (ASM) in Auckland on 24
September 2024, which contrasts to the previous expectations communicated in
Pacific Edge's Q1 24 investor update released to the NZX and ASX on 10 July
2024. The review of the AUA microhematuria guideline, which was last amended
2020, is potentially significant as guidelines play a substantial role in
medical reimbursement policy for Medicare and all other payers. They also
have a significant influence over the practices of individual urologists."
On the face of it a "good news" outcome seems possible, or maybe even likely, but this is the US medical market - and as we've already seen - everything seems to take forever and it's all pretty opaque.
The current situation remains highly speculative IMHO.
Timeline for final decision seems to be 3 to 12 months. In my opinion could go either way lets say 50/50 chance of either outcome. The upside conservatively must be at least 60 cent gain, sp 75 cents. The downside a 7 cent loss sp 8 cents
Nothing is certain but worth a punt maybe.
Whilst the share price action is nice I see a fall after the ASM next week, unless the yanks at AUA/Novitas make a decision in the next week and I certainly don't see that happening on information we have
Quote from: Greekwatchdog on Sep 18, 2024, 11:04 AMWhilst the share price action is nice I see a fall after the ASM next week, unless the yanks at AUA/Novitas make a decision in the next week and I certainly don't see that happening on information we have
Not sure about that - the SP fall after the ASM I mean - because, as Pierre noted, PEB have explicitly said that no decision will be made before then. More likely in 3-6 months I feel. The SP action is purely on the news that the AUA are to review their guidelines. It's not guaranteed by any stretch that the review will include PEBS products in the guidelines, but there's a reasonable chance that they will. If that happens, punters will see a pretty good, immediate, return on their investment. If not, then the SP will retrench. Risk, reward and the thrill of the chase!
A welcome bit of caution returning to the market today - closed at 15.3 after reaching an irrational 18.5.
Must have been a few grinners - and a few burnt fingers - after 5.2m shares changed hands today.
Its good to see some well placed attention and interest on the stock. This stock was the darling of 2020, if they pull off the AUA it might happen again.
Quote from: Habitz on Sep 18, 2024, 09:11 PMIts good to see some well placed attention and interest on the stock. This stock was the darling of 2020, if they pull off the AUA it might happen again.
Lost that darling status when Darling left
Quote from: winner (n) on Sep 19, 2024, 08:01 AMLost that darling status when Darling left
Thats true. We need someone with a new surname for the current challenges, to create the right impression, to take us to new heights of success, a name like "winner" will do.
Quote from: winner (n) on Sep 19, 2024, 08:01 AMLost that darling status when Darling left
That's Captain Darling....
Excellent synopsis presented by Pierre on the other site.
Totally agree that we are perhaps at the beginning of a chain of events starting with PEB getting included in the new AUA guidelines and ending with Novitas re-instating permanent coverage. The time frame for that is anyone's guess, but mine is 6 months or less.
Getting included in the new AUA guidelines is key, not just to put pressure on Novitas, but for the fact that the they govern the practices of all urologists. I think there's only something like 12% of urologists in the US that currently have used CXBladder, but if the new guidelines explicitly endorse and recommend its use as a safe, accurate, screening tool, then PEB's use by practitioners will go through the roof, as will throughput and revenue.
I hope that's how things turn out, not just because I hold far more stock than is sensible, but because I've always believed in the positive health benefits that PEB's products provide. That's the true double-bagger: making money whilst doing good ;D
I'm currently in Japan where I tried to log on to the PEB ASM on my phone. Unfortunately the virtual meeting technology only works on a PC so I can't access the meeting.
I will appreciate an update of any pertinent information from anyone who is able to attend either in person or online.
Quote from: Pierre on Sep 24, 2024, 01:21 PMI'm currently in Japan where I tried to log on to the PEB ASM on my phone. Unfortunately the virtual meeting technology only works on a PC so I can't access the meeting.
I will appreciate an update of any pertinent information from anyone who is able to attend either in person or online.
You're more on the ball than I Pierre. Forgot to log-in entirely. The presentation and Chairmans address is now on the PEB website.
The presentation sounds fairly positive as you would expect, but wisely they are not trying to predict anything around the upcoming new AUA guidelines and the Novitas decision other than noting "the direction of travel" from the Strata study and strong industry support.
Not sure if there was anything revelatory in the Q/A session?
Quote from: LoungeLizard on Sep 24, 2024, 03:09 PMYou're more on the ball than I Pierre. Forgot to log-in entirely. The presentation and Chairmans address is now on the PEB website.
The presentation sounds fairly positive as you would expect, but wisely they are not trying to predict anything around the upcoming new AUA guidelines and the Novitas decision other than noting "the direction of travel" from the Strata study and strong industry support.
Not sure if there was anything revelatory in the Q/A session?
I haven't heard anything other than what I read which is positive with work to do to get over the line. Not surprised at share price falling. Market got a little carried away for mine
Quote from: Pierre on Sep 24, 2024, 01:21 PMI will appreciate an update of any pertinent information from anyone who is able to attend either in person or online.
Re PEB ASM 24/9/24
I watched/listened to today's meeting online because PEB is one of very few underperforming companies in my otherwise beautiful and profitable portfolio!
It was a very long meeting.... over 2 hours
Some notes FWIW
- No assurances or timeline re Novitas were given, (hence the drop in SP today?) IMHO these expectations were unrealisitc at this time. Novitas runs to its own schedule.... not to PEB's.
- Any selection of a new Chairperson for PEB is on hold until a Novitas decision is made.Current Chair has agreed to remain in place to allow orderly transition.
- In all respects the meeting was extremely positive.
- The buffer of $53 mill on hand is being managed prudently until such time as further progress can be made in terms of Novitas and revised AUA guidelines
- After today's ASM the Board and key managers are having a 2 day retreat for future plans which will cover a.) recovery under a negative Novitas decision. b.) Accelerated growth under a positive decision.
- PEB very positive that the seperate (and timely) AUA guideline review will conclude with positive benefits to PEB (possible timeline not given..... I estimate as likely in FY25.)
- PEB progressing strongly with other initiatives. eg an online customer portal has just been launched (after trials with Kaiser) and will increase efficiencies and accurate data collection.
- New product Detect Plus (Detect+) has huge potential as is much superior to current PEB products and is ready for launch as soon as agreement on pricing is reached with US authorities.
- CEO Peter Meintjes impresses as very skilled and knowledgeable in these difficult times.
- The CEO noted that PEB has now weathered the storm for 2 years and PEB are now seeing more options for positive progress than they are for negative.
- In the Q & A session the Q of possible legal action against Novitas was raised. PEB is prepared for this, but does not see it as a priority. Any legal action will depend on the circumstances and will not be 'at huge cost' as PEB would prefer to spend its $'s on research to validate its clinical utility.
USA remains the priority market
- The newly formed Medical Affairs team has been a great success. (Doctors talking to Doctors are much more effective than sales people talking to Doctors.)
The meeting included slides which can be seen here; https://api.nzx.com/public/announcement/438709/attachment/427932/438709-427932.pdf
ps.... I note I have now topped 1,000 posts and that is likely enough for me. I'm not planning on posting any more.
Best wishes all..... I'll be watching from afar.
"a.) recovery under a negative Novitas decision. b.) Accelerated growth under a positive decision."
A TWO horse race where option a.) is partial loss and option b.) is multibag 5 or 10:1 ??
Great summary Left Field.
Also worth noting CEO mentioned companies aren't usually asked by the AUA to be involved in guideline discussions, so interesting PEB consultant was asked to contribute.
Quote from: Left Field on Sep 24, 2024, 04:08 PMRe PEB ASM 24/9/24
I watched/listened to today's meeting online because PEB is one of very few underperforming companies in my otherwise beautiful and profitable portfolio!
It was a very long meeting.... over 2 hours
Some notes FWIW
- No assurances or timeline re Novitas were given, (hence the drop in SP today?) IMHO these expectations were unrealisitc at this time. Novitas runs to its own schedule.... not to PEB's.
- Any selection of a new Chairperson for PEB is on hold until a Novitas decision is made.Current Chair has agreed to remain in place to allow orderly transition.
- In all respects the meeting was extremely positive.
- The buffer of $53 mill on hand is being managed prudently until such time as further progress can be made in terms of Novitas and revised AUA guidelines
- After today's ASM the Board and key managers are having a 2 day retreat for future plans which will cover a.) recovery under a negative Novitas decision. b.) Accelerated growth under a positive decision.
- PEB very positive that the seperate (and timely) AUA guideline review will conclude with positive benefits to PEB (possible timeline not given..... I estimate as likely in FY25.)
- PEB progressing strongly with other initiatives. eg an online customer portal has just been launched (after trials with Kaiser) and will increase efficiencies and accurate data collection.
- New product Detect Plus (Detect+) has huge potential as is much superior to current PEB products and is ready for launch as soon as agreement on pricing is reached with US authorities.
- CEO Peter Meintjes impresses as very skilled and knowledgeable in these difficult times.
- The CEO noted that PEB has now weathered the storm for 2 years and PEB are now seeing more options for positive progress than they are for negative.
- In the Q & A session the Q of possible legal action against Novitas was raised. PEB is prepared for this, but does not see it as a priority. Any legal action will depend on the circumstances and will not be 'at huge cost' as PEB would prefer to spend its $'s on research to validate its clinical utility.
USA remains the priority market
- The newly formed Medical Affairs team has been a great success. (Doctors talking to Doctors are much more effective than sales people talking to Doctors.)
The meeting included slides which can be seen here; https://api.nzx.com/public/announcement/438709/attachment/427932/438709-427932.pdf
ps.... I note I have now topped 1,000 posts and that is likely enough for me. I'm not planning on posting any more.
Best wishes all..... I'll be watching from afar.
An excellent summery of the meeting Left field.
Quote from: Left Field on Sep 24, 2024, 04:08 PMRe PEB ASM 24/9/24
ps.... I note I have now topped 1,000 posts and that is likely enough for me. I'm not planning on posting any more.
Best wishes all..... I'll be watching from afar.
A thousand posts? That's a long tour of duty!
I've appreciated your comments and insights -take a well earned furlough!
Thanks so much Left Field - I really appreciate your comprehensive summary.
More watching and waiting required now, but it does seem there are grounds for a potentially positive outcome. How positive and for how long do we have to wait, are the unanswerable questions.
I understand biotech patents are important for the US market (which is the PEB focus, for now) but the patents on the PEB website do not mesh with what can be seen online at the US patent office. It appears they have a handful of US patents and applications in progress.
Found here: https://ppubs.uspto.gov/pubwebapp/static/pages/ppubsbasic.html
Patent numbers, expiry dates & {brief description}:
- 10689707 expired {gastric cancer treatment} - see 10024859 below
- 11180815 exp 2027 {colorectal cancer treatment}
- 10689711 exp 2027 {urothelial carcinoma treatment} - see 10131955 below
- 9809860 exp 2028 {test kits & genetic markers}
- 9534258 exp 2028 {melanoma patent mentioned on their website}
- 10024859 exp 2030 {detecting gastric cancer markers}
- 11208698 exp 2032 {bladder cancer markers detection}
- 10131955 exp 2034? {detecting biomarkers of urothelial carcinoma}
Plus about 14 other applications from what I can see.
They don't seem to mention all the US patents on this page:
https://www.pacificedgedx.com/company/intellectual-property/
Probably worth asking about given biotech patents have the potential for huge values, and huge lawsuits.
Darkest before dawn...? Certainly looking dark while awaiting acceptance
Quote from: Habitz on Nov 26, 2024, 11:24 AMDarkest before dawn...? Certainly looking dark while awaiting acceptance
We've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.
Quote from: LoungeLizard on Nov 26, 2024, 01:04 PMWe've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.
Pick your best definition eh - I like that
to be far advanced, ahead, well gone, long gone, distant - usually followed by atu or mai. Ka oti te takutaku ka tukua te teka kia rere, kātahi ka ...
Quote from: LoungeLizard on Nov 26, 2024, 01:04 PMWe've had years off famine but there could be a veritable feast for investors if Novitas change their minds and the AUA include CXBladdder in the new guidelines. All speculation of course, but I'm fairly confident that at least one of those things will come to pass, which would be a game-changer in itself.
Are there any expected timeframes on these?
Quote from: SuperMario on Nov 28, 2024, 01:21 AMAre there any expected timeframes on these?
No there is not. Novitas are currently on extension, so answer could come anytime.
December update ex Facebook. Link below
https://www.cxbladder.com/assets/New...n-Dec-2024.pdf
Bad news as expected.
" As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and are therefore, are not payable.'
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39365&ver=131&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=noticeStart&bc=11
No announcement on NZX. Maybe they don't know yet or still on holiday.
Quote from: Shareguy on Jan 10, 2025, 08:34 AMNo announcement on NZX. Maybe they don't know yet or still on holiday.
I imagine we will get a trading halt until they sort their interpretation of what this means out.
Just another hiccup on the long road to success
No worries, just be patient
Trading halt..... CMS results not looking good for holders as per Shareguys post #396 above.
https://api.nzx.com/public/announcement/444922/attachment/435451/444922-435451.pdf
Had a look at Craig's latest note from 27/11
prior sections we outline our conservative expectation that PE coverage in FY26 but regain it in FY28. This will effect:
Test volumes: We think Medicare coverage loss will reduce non-Kaise 80% from 11k in FY25 to only 2k in FY25. This is because only 40% o volumes are not paid for by Medicare, and we assume 50% of these ch cuts and constraints on which customers PEB can sell to. We expect r remain flat at 2k up to FY28 when a resumption of coverage allows a r growth commensurate with when volumes were last at a similar le growth reducing slightly over time as non-Kaiser volumes return to FY of coverage will set non-Kaiser volumes back 6 years.
We expect a ramp in Kaiser volumes will offset some of this decline, pr cash flow over the period (which importantly does not require signific think Kaiser volumes will ramp from 26% of volumes presently to 68% ir
Costs: Post coverage loss, we think PEB will slash S&M costs 70% and levels) by the end of FY26. We think R&D will remain flat for the expenses will remain at this muted level until FY28 when coverag expenses will return to levels commensurate with what they were whe a similar level.
By these numbers, PEB will need to raise $35m in equity
Quote from: Left Field on Jan 10, 2025, 09:33 AMTrading halt..... CMS results not looking good for holders as per Shareguys post #396 above.
https://api.nzx.com/public/announcement/444922/attachment/435451/444922-435451.pdf
"The determination covers significant new information and Pacific Edge needs time to assess the
implications of the announcement, consult with US legal advisers and industry partners, and prepare
an announcement that provides context to investors."
That doesn't sound too promising, unfortunately. It is hard to see how Novitas could remove coverage and on what grounds, given the industry support and successful trials, but that seems to be what is being implied, hence the involvement of legal advisors. It will be blow to PEB's prospects if coverage is removed, but probably not fatal as per Craig's analysis. The wait goes on. Sigh.
Arggh - it does indeed sound as though coverage will be removed:
"In conclusion, the Cxbladder line of tests all suffer from insufficient test validation, a foundational problem in which potentially confounding clinical circumstances include non-TCC neoplasms and malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including a foundational study from Holyoake in 2008 that only used Japanese patients from one location.28 Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers, particularly when there are issues not discussed in Pacific Edge Diagnostic funded papers that are subsequently addressed by non-funded studies, such as the 2019 Davidson study which identified increased false positives in patients with non-TCC malignancies.41 As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and are therefore, are not payable.'
Wonder what the hit to the SP is going to be???
Amazing - not really following this stock, but just noticed - its now 20 years that PEB was good for generating hype without end - and punters always hoping that this next move creates the break through. TWENTY years and some amazing decks! Did I miss the party?
Screenshot 2025-01-10 104304.png
Interesting SP movement - apart from two lonely peaks (great for traders in the know) nothing happened - but hey, plenty of traders make money as well from the jitter, and clearly - the investors and believers did pay.
No doubt, though - this time it will be different, and hey - if its a (hype-) cyclical, then the next peak might be in 2028/29 ... but - don't take my word for it :) ;
Quote from: LoungeLizard on Jan 10, 2025, 10:42 AMArggh - it does indeed sound as though coverage will be removed:
"In conclusion, the Cxbladder line of tests all suffer from insufficient test validation, a foundational problem in which potentially confounding clinical circumstances include non-TCC neoplasms and malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including a foundational study from Holyoake in 2008 that only used Japanese patients from one location.28 Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers, particularly when there are issues not discussed in Pacific Edge Diagnostic funded papers that are subsequently addressed by non-funded studies, such as the 2019 Davidson study which identified increased false positives in patients with non-TCC malignancies.41 As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and are therefore, are not payable.'
Wonder what the hit to the SP is going to be???
Me thinks $0.05 to $0.075.
Quote from: Greekwatchdog on Jan 10, 2025, 10:52 AMMe thinks $0.05 to $0.075.
Yes I agree. The issue I see is I can't see a lot of institutional support or for that matter large retail investors stumping up for a CR.
There is still the result of the AUA guidelines review to come, which may see CxBladderapproved for use.
Should that occur it would give PEB a pretty strong basis for appealing the Novitas decision.
I hope they keep their powder dry pending release of the AUA outcome before commencing legal action.
Didn't the AUA update guidelines in 2024? Also from Novitas decision:
"... systemic reviews, meta-analyses and even guidelines from large expert organisations like the American Urological Association generally do not support the use of Cxbladder tests in patient care. At best, the guidelines "support their potential value in preventing unnecessary cystoscopies"..."
Seems like a little bit clutching at straws now to think that the AUA are gonna white knight this one. Disappointed as I dipped my speculative little toe in at 11c and like others I can see this down at 5c next week.
Quote from: raW tent Buffer on Jan 10, 2025, 12:59 PMDidn't the AUA update guidelines in 2024? Also from Novitas decision:
"... systemic reviews, meta-analyses and even guidelines from large expert organisations like the American Urological Association generally do not support the use of Cxbladder tests in patient care. At best, the guidelines "support their potential value in preventing unnecessary cystoscopies"..."
Seems like a little bit clutching at straws now to think that the AUA are gonna white knight this one. Disappointed as I dipped my speculative little toe in at 11c and like others I can see this down at 5c next week.
Novitas's claim that the AUA are lukewarm on CXBladder seems contrary to their quite vocal support and positive submissions on behalf of CXBladder. The joint submission from the AUA and other other urological institutions said this:
"It is our belief that the proposed modifications to coverage criteria are incorrectly applied to
urine-based tumor markers, and thus finalizing the draft policy as written will have adverse
impacts on the provision of high-quality patient care while ultimately increasing system costs.
"Furthermore, the Draft LCD does not utilize the widely accepted standards for these tests found
in guidelines promulgated by the AUA and Society of Urologic Oncology (SUO). AUA guidelines
are the specialty of urology's well established and accepted governing resource and should be
included when promulgating an LCD of this nature."
They then went on to dismantle Novitas's concerns about demographic bias, and clinical evidence. Seems to me that the AUA have given a clear message to Novitas that they fully support CXBladder and for Novitas to suggest otherwise is a very shaky position to hold. If it did go to court it would be hard to see how Novitas could maintain this position.
That said, if the AUA really are supportive, they need to include CXBladder in their guidelines and to some extent, if they did that, and it became part of recommended standard urological procedure, it's hard to see how Novitas could continue to ignore it. Balls in the AUA's court to come out swinging.
Quote from: Greekwatchdog on Jan 10, 2025, 08:44 AMI imagine we will get a trading halt until they sort their interpretation of what this means out.
I think you mean there will be a trading halt until they figure out how to spin more bullsh*t to shareholders.
Reading the Novitas release I note they mentioned a number of times "FDA approved" including in their approval of just one test from those impacted by this LCD:
"UroVysion: This FDA-approved adjunctive test is intended for use in conjunction with and not in lieu of current standard diagnostic procedures to aid in the initial diagnosis of bladder carcinoma in patients with persistent hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer"
I wonder if it was a grave omission by PEB not to seek FDA approval for CXB during the 2 years this LCD was being considered? FDA approval appears to carry some weight and expectedly so IMHO, easy to base a decision on what an officially designated government department says about a product you are reviewing.
Quote from: KW on Jan 11, 2025, 12:46 PMI think you mean there will be a trading halt until they figure out how to spin more bullsh*t to shareholders.
perfect description on how this company operates
Quote from: snapiti on Jan 11, 2025, 09:26 PMperfect description on how this company operates
Yes. They will no doubt dress this up with "plenty of spin"
For anyone looking at buying I would suggest they consider how much of his own money did the current ceo invest in shares other than some freebies...
And how many shares does the old CEO own currently......
I think the share price will settle over 7 c as there is still a lot of investors with that dream and analysts such as Craig's have for some time said that coverage loss is most likely, therefore already baked into the sp.
Good luck.
Quote from: Shareguy on Jan 12, 2025, 12:26 PMYes. They will no doubt dress this up with "plenty of spin"
For anyone looking at buying I would suggest they consider how much of his own money did the current ceo invest in shares other than some freebies...
And how many shares does the old CEO own currently......
I think the share price will settle over 7 c as there is still a lot of investors with that dream and analysts such as Craig's have for some time said that coverage loss is most likely, therefore already baked into the sp.
Good luck.
At least the likes of ANZ won't be rushing to the exit doors
Bad news 'already baked into share price' is often phrase used by punters who desperately hope carnage won't be happening.
I can't help wondering if Forbar might have another go at milking this for yet another capital raise underwriting fee.
This capital raise will be enough to see PEB through to commercial success and we really mean it this time.
I think anyone investing in PEB knows it is high risk / high return. Many investors have a few "fun" stocks their portfolio (gold mining anyone?) akin to spending $500 a year in lottery tickets or having a few days at the races.
I do, however, believe that PEBs' products have proven themselves time and again in trials and there seems to be a groundswell of industry support for bio-marking as a diagnostic tool. The main problem they have faced (together with covid) is that the US health/pharmaceutical industry is run like a cartel and is inherently resistant to change. As bonkers as some of his views are, RFK Jr has made it clear that he wants to open up both industries to cost saving initiatives. Good luck to him.
What the impact on the SP is going to be depends on the big investors like ANZ. If they exit their positions then all hell will break loose. If not, I doubt many retail investors will sell - we are in it for the long haul. Probably 6-7c and then maybe recovering depending on PEBS and the AUA's response.
Quote from: LoungeLizard on Jan 12, 2025, 02:13 PMWhat the impact on the SP is going to be depends on the big investors like ANZ. If they exit their positions then all hell will break loose. If not, I doubt many retail investors will sell - we are in it for the long haul. Probably 6-7c and then maybe recovering depending on PEBS and the AUA's response.
Not far off....trading in the 5c-6c range in the first 40 minutes this morning. Largest trades so far are 2 x blocks of ~400k shares. The rest is rats and mice.
Did anyone proofread this before it was released? Doesn't give a lot of confidence that they can't seem to put together a properly written statement despite having the entire weekend to do it...
QuoteNovitas finalizes non-coverage determination
13/01/2025, 09:24 NZDT, GENERAL
Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today notes that Novitas, the Medicare Administrative Contractor with jurisdiction for our US laboratory, on Thursday 9 January 2025 finalized a non-coverage determination that would end reimbursement for Cxbladder Triage, Detect and Monitor by Medicare.
The draft Local Coverage Determination (LCD) 'Genetic testing for oncology' (DL39365) has been finalized under a new title 'Genetic Testing in Oncology: Specific Tests' (L39365). The LCD reverses Novitas' July 2020 determination that provided for Medicare coverage of Cxbladder. If not challenged, the finalized LCD would become effective in 45 days from the date of publishing, with reimbursement of Pacific Edge's Cxbladder tests Triage, Detect and Monitor ceasing on 23 February 2025.
The new 'Genetic Testing in Oncology: Specific Tests' (L39365), acknowledges some shortcomings of the original draft LCD (DL39365), but remains flawed, particularly in its review of the clinical evidence underpinning Cxbladder tests.
Specifically, Novitas:
- Continues to misunderstand the current standard of care in evaluating hematuria patients, and the important role that biomarkers can play in stratifying patients with hematuria into those that would benefit from further potentially more invasive medical attention and those that would not.
- Fails to consider new peer reviewed evidence supporting the use of Cxbladder published since the revised draft determination in July 2023, despite having been notified of the evidence and stating in writing that it would incorporate that evidence in the review. Specifically, Novitas has not reviewed or cited:
- the ground-breaking STRATA randomized control study published in July 2024, which demonstrated the Clinical Utility (CU) of Cxbladder Triage and importantly that this study showed that clinicians undertook 59% fewer cystoscopies, when provided with a Triage test result; and
- the analytical validation data of Cxbladder Detect, Triage and Monitor published in September 2024.
- Repeats its flawed analysis of the existing clinical evidence for Cxbladder tests by focusing on the biomarker discovery study by Holyoake et al in 2008 and creates confounded conclusions by lumping the evidence in future publications from all assays together and not the clinical evidence supporting the individual products.
Pacific Edge Chairman Chris Gallaher said: "We are disappointed by Novitas' determination, which has been made despite strong representations from Pacific Edge, many key opinion leaders in urology, bladder cancer patient advocates and the molecular diagnostics industry.
"Nevertheless, it is an outcome for which Pacific Edge has prepared. Following the release of the draft determination (DL39365) in late July 2023, and in recognition of the elevated risk of a decision such as this, we restructured our business to reduce our cash burn.
"With the LCD finalized, we are now activating the contingency plans and strategies to further reduce our expense base until we regain reliable Medicare coverage. With $28.5 million in reserves as at the end of December 2024, the company the company is well placed to fund the re-coverage process if necessary and regain reimbursement for our tests," Mr Gallaher said.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are disappointed by a finalized LCD that misunderstands the science of biomarker discovery and diagnostic test development in the context of the standard of care in urology. We are do not understand its framing of Cxbladder as a screening test of asymptomatic patients and at the failure to acknowledge the views of the American Urological Association (AUA) and the practicing clinicians that derive value from the test.
"Furthermore, we cannot believe that Novitas would commit in writing to review our most recent evidence (the STRATA study and recent analytical validation data) as part of developing this LCD and then fail to do so. Ignoring a randomized controlled trial (classified as Level 1 Evidence) published during the lengthy deliberations on the LCD and the consensus of the urology community runs counter to the mandate of a US government health insurance program, Dr Meintjes said.
"Regardless, we are prepared to continue to do what is best for our investors, physicians and patients."
Dr Meintjes said the go-forward plans may include the following:
- Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors.
- Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage.
- Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor.
- Continue to explore other strategic alternatives for Pacific Edge that could support the company through to regaining reliable Medicare coverage and advancing the commercialization of Cxbladder globally.
Dr Meintjes emphasized that the long-term focus of the company remains unchanged and that the team is looking forward to the outcome of the AUA's ongoing review of its microhematuria guideline following the publication of the STRATA study. The possibility of AUA Guidelines inclusion creates additional potential for a reconsideration request for Medicare coverage to Novitas.
Pacific Edge is currently unable to fully determine the impact of the new LCD on test volumes in the US market for the remainder of the 2025 financial year and beyond, but in 1H 25 Medicare and Medicare Advantage delivered ~5,300 commercial tests (~54% of US commercial tests) and ~$6.5m NZD in total operating revenue.
The company expects to continue to bill and receive reimbursement from contracted US payers without interruption, notably Kaiser Permanente and the US Veterans Administration, and from non-contracted private payers in line with historic reimbursement rates. Similarly, Pacific Edge expects collections from the enhanced patient responsibility and patient assistance programs to continue in line with the rates since the introduction of that program in July 2023.
Dr Meintjes said: "While this determination will have an impact on our current and future commercialization plans, it simultaneously emphasizes that our focus on rigorous clinical evidence generation as a path to gaining coverage certainty through guidelines inclusion is the right focus for our business. This program is at the center of our efforts to regain Medicare coverage.'
Pacific Edge will be hosting a conference call and webcast to discuss the determination today (Monday 13 January 2025) at 11.00am NZST:
This update will be available via webcast by the following link: www.virtualmeeting.co.nz/pebiu25 or by phone on the following toll-free numbers:
the go-forward plans may include the following:
- Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors though we will enjoy spending your money instructing lawyers at the best Michelin starred American restaurants.
- Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage however the executive team is safe till the money runs out.
- Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor. Take that you ignorant fockers.
- Continue to explore other strategic alternatives for Pacific Edge that could support the company through to receivership.
Well the market does not like it. I can see a share consolidation followed by a cap raise. Even then it's going to be heavily discounted. Chances of getting coverage again are very very slim in my opinion. What's left...
Quote from: Crackity on Jan 13, 2025, 11:36 AMthe go-forward plans may include the following:
- Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors though we will enjoy spending your money instructing lawyers at the best Michelin starred American restaurants.
- Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage however the executive team is safe till the money runs out.
- Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor. Take that you ignorant fockers.
- Continue to explore other strategic alternatives for Pacific Edge that could support the company through to receivership.
Love it. Sales growth going no where in years despite this huge market and over $200m of investors money spent so far.
Pretty good conference call I thought. My positive interpretation is that some form of AUA guidance inclusion seems to expected, and that (and the clinical trial evidence that supports the inclusion) should form a strong basis to challenge the Novitas decision. Seems like the major investors are still supportive at this stage.
Quote from: Shareguy on Jan 13, 2025, 11:49 AMWell the market does not like it. I can see a share consolidation followed by a cap raise. Even then it's going to be heavily discounted. Chances of getting coverage again are very very slim in my opinion. What's left...
PEB say that they have sufficient funds to see through the appeal/re-application process, so a cap raise before that is unlikely and unwise. Negative market reaction was, of course, expected.
Quote from: Crackity on Jan 13, 2025, 11:36 AMthe go-forward plans may include the following:
- Pursuing a preliminary injunction and legal challenge to the finalization of the LCD. Pacific Edge notes and recognizes the inherent uncertainty of success in these endeavors though we will enjoy spending your money instructing lawyers at the best Michelin starred American restaurants.
- Further review the structure of our operations and our strategy to reduce cash burn in line with our plan to regain reliable Medicare coverage however the executive team is safe till the money runs out.
- Submit to Novitas a Medicare coverage reconsideration request on the basis of the Journal of Urology's publication of the STRATA study and the updated Analytical Validation studies of Triage, Detect and Monitor. Take that you ignorant fockers.
- Continue to explore other strategic alternatives for Pacific Edge that could support the company through to receivership.
Pity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.
Navigating the US Healthcare minefield is proving to be a hell of a task and probably much more difficult than anyone in this part of the world ever envisaged.
Sure, there's been lots of money invested and miss-steps along the way, but the journey is not over yet. The company still has cash in the bank and the prospect of inclusion in the AUA Standard of Care Guidelines.
I'm a long-term holder and PEB supporter with fingers crossed for a positive outcome for CMS coverage, if not now, then within the next 2-3 years.
Quote from: LoungeLizard on Jan 12, 2025, 02:13 PMI think anyone investing in PEB knows it is high risk / high return. Many investors have a few "fun" stocks their portfolio (gold mining anyone?) akin to spending $500 a year in lottery tickets or having a few days at the races.
I think that's widely understood by professional or experienced investors and in particular in other much deeper markets with a vast number of biotech stocks such as America where most are well aware its either hit or miss and far more likely to be a miss and lose all your money. That said, I do wonder whether one particular broker of note that writes supportive research just before they cash in on millions of underwriting fees, on a regular repeating basis doesn't draw in a new bunch of vulnerable or gullible investors each time? Some of these newer investors are gullible enough to treat analyst reports like they're the ten commandments chiseled in stone brought down from the mountain.
The best analogy I can think of after drinking a few bottles of cider on the weekend, on the side of the bottle there was a bold and prominent warning to pregnant women. Words to the effect, to the best of my recollection, that said WARNING CONSUMPTION OF ALCOHOL BY PREGANT WONEN CAN CAUSE SERIOUS LIFE LONG IRREVERSIBLE DAMAGE TO YOUR BABY.
Maybe these repetitive capital raises should come with a mandatory warning like this. WARNING, ITS A WELL KNOWN FACT THAT THE VERY BEST WAY TO MAKE A SMALL FORTUNE WITH BIOTECH COMPANIES IS TO START WITH A MUCH BIGGER ONE.
You can't really get higher risk than unconsented gold mining ventures or biotech companies...you and I and many other experienced investors know this and allocate a very small percentage of our portfolio accordingly, but other less experienced vulnerable investors, maybe are risking lifelong irreversible damage to their retirement plans with a much bigger portfolio allocation, some of which may have been selected for them by not so well meaning brokers with full discretionary management of some clients funds.
Quote from: Pierre on Jan 13, 2025, 02:58 PMPity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.
Navigating the US Healthcare minefield is proving to be a hell of a task and probably much more difficult than anyone in this part of the world ever envisaged.
Sure, there's been lots of money invested and miss-steps along the way, but the journey is not over yet. The company still has cash in the bank and the prospect of inclusion in the AUA Standard of Care Guidelines.
I'm a long-term holder and PEB supporter with fingers crossed for a positive outcome for CMS coverage, if not now, then within the next 2-3 years.
...and Bryan Williams is still a Director .....hanging in there and hoping for the best
Quote from: Crackity on Jan 13, 2025, 03:14 PMI see a Board and management that are at best permanently wearing rose tinted spectacles and at worst are economical with the truth.
Aroa looks a much better bet for making it big on the international stage to me.
Are you suggesting that a large number of experienced investors including those such as Tindall and ANZ have been sucked in by a bunch of liars?
I don't think anyone here would have invested in PEB not knowing the risks involved. And, given the risks, no-one is going to put their shirt on it. Buy a good chunk of shares for a few thousand dollars and see how it goes. And in the meantime support a NZ company producing an innovative, life saving product. We all do our own research and measure the risks and reward. Nothing naive or gullible about that.
I think PEB have got a strong chance of getting included in the new AUA guidelines, which would be a major breakthrough in itself, whilst also providing a firm basis for appeal of the Novitas decision.
I wonder if PEB really has a future
Quote from: winner (n) on Jan 13, 2025, 06:41 PMI wonder if PEB really has a future
Of course they have a future. Product works. It needs the AUA to get it in the guide lines.
This out of the Herald this evening
At home, Pacific Edge fell 7.4c or 55.22% to 6c after telling the market that Medicare contractor Novitas finalised a non-coverage determination that would end reimbursement for its Cxbladder tests. If not challenged, the payments will finish on February 23.
Pacific Edge said Novitas continued to misunderstand the current standard of care in evaluating hematuria patients, and the important role biomarkers can play in stratifying patients with hematuria into those who would benefit from further potentially more invasive medical attention and those who would not.
The cancer diagnostic company said it would pursue a preliminary injunction and legal challenge, while further reviewing its operational structure and cash burn in line with the plan to regain reliable Medicare coverage.
Pacific Edge will submit a Medicare coverage reconsideration request to Novitas based on the Journal of Urology's publication of the Strata study and the updated Analytical Validation studies of Triage, Detect and Monitor.
Goodson said it was deeply frustrating for Pacific Edge, which has a product that appears to be a better widget but is having trouble commercialising it, and the clock is ticking on its cash reserves (of $28.5m).
"It has become even more important for the Cxbladder tests to be included in the American Urology Association standard of care guidelines which are due out any time now. If that happens, Pacific Edge will be well placed. It's not the end of the road for them," Goodson said.
Quote from: Crackity on Jan 13, 2025, 07:18 PMlol
Summary of substantial holding
Class of quoted voting products: Pacific Edge Limited Ordinary Shares (PEB)
Summary for Salt Funds Management Limited
For this disclosure,—
(a) total number held in class: 48,114,089
(b) total in class: 809,410,844
(c) total percentage held in class: 5.944%
For last disclosure,—
(a) total number held in class: 50,675,987
(b) total in class: 728,279,398
(c) total percentage held in class: 6.952%
Details of transactions and events giving rise to relevant event:
On 28 September Salt Funds Management took part PEBs institutional placement. This
amounted to 5,147,730 shares and a dollar value of $6,949,435.50. On 5 October Salt
Funds Management took part PEBs Share Purchase Plan. This amounted to 152,211 shares
These guys trade shares all the time, just like att the other firms. Thats all you have got? In 2.5 years since Novitas annouced that were cutting funding very few have sold. Good grief
Quote from: Pierre on Jan 13, 2025, 02:58 PMPity about the cynicism when we have a New Zealand based company trying to make it big on the international stage with a product designed to benefit bladder cancer sufferers.
Trust is destroyed when time after time after time they tell porkies that this capital raise will see us through to commercial success. You can only "cry wolf" so many times before people say, you're full of it. They can't even construct an NZX stock exchange release in proper English that's proofread before its released so why would you trust them to navigate all the intricate challenges involved with international certification?
PEB is set to no longer receive reimbursement for its Cxbladder tests from CMS in the US from 23 February 2025. This represents ~60%–70% of its revenue. That's huge.
The upcoming American Urological Association (AUA) guidelines review. If positive, this will act as a key mechanism for PEB to lodge a coverage reconsideration request; if negative, the path forward looks challenged.
FB latest note not very positive and no longer offering a target price. I note that FB own a significant amount of shares on behalf of investors as at last annual report.
Craig's latest underperform (sell in my book) 5 cents.
Is it even worth 5 cents for "a punt" which is all it is. I don't think so. If I was interested I would wait for the upcoming review, if it's negative I reckon it's all over as far as a reversal of the Novitas decision.
A shame really. PEB harp on about how huge the market is in the world and US but it seems doctors are not really buying it. World sales are "corner dairy" stuff and the growth in the US was very small when you consider the market size.
Notice the ceo got $867 in cash remuneration and $22k in shares according to the 2024 annual report. In fact a pay rise from 2023 and was awarded 73 percent of his sti. All for a company that has a very low turn over and has lost over $240m of shareholders funds so far. I also note there are 25 employees earning over $300k. Maybe it's time to review this....
I just hope it survives and best of luck to holders
Quote from: Shareguy on Jan 14, 2025, 11:14 AMPEB is set to no longer receive reimbursement for its Cxbladder tests from CMS in the US from 23 February 2025. This represents ~60%–70% of its revenue. That's huge.
The upcoming American Urological Association (AUA) guidelines review. If positive, this will act as a key mechanism for PEB to lodge a coverage reconsideration request; if negative, the path forward looks challenged.
FB latest note not very positive and no longer offering a target price. I note that FB own a significant amount of shares on behalf of investors as at last annual report.
Craig's latest underperform (sell in my book) 5 cents.
Is it even worth 5 cents for "a punt" which is all it is. I don't think so. If I was interested I would wait for the upcoming review, if it's negative I reckon it's all over as far as a reversal of the Novitas decision.
A shame really. PEB harp on about how huge the market is in the world and US but it seems doctors are not really buying it. World sales are "corner dairy" stuff and the growth in the US was very small when you consider the market size.
Notice the ceo got $867 in cash remuneration and $22k in shares according to the 2024 annual report. In fact a pay rise from 2023 and was awarded 73 percent of his sti. All for a company that has a very low turn over and has lost over $240m of shareholders funds so far. I also note there are 25 employees earning over $300k. Maybe it's time to review this....
I just hope it survives and best of luck to holders
I think something like 10% of US urologists have employed CXBLAdder in their practice, but you're right, the key milestone now is to have the AUA give it further endorsement by having it included in the guidelines. If that happens, my understanding is that all urologists would be obliged to use it, in the appropriate cases, as a screening tool to avoid unnecessary, costly and invasive cystoscopies. I gather from the conference call that it will be about 3 months for the new guidelines to be made public.
Quote from: LoungeLizard on Jan 14, 2025, 01:33 PMI think something like 10% of US urologists have employed CXBLAdder in their practice, but you're right, the key milestone now is to have the AUA give it further endorsement by having it included in the guidelines. If that happens, my understanding is that all urologists would be obliged to use it, in the appropriate cases, as a screening tool to avoid unnecessary, costly and invasive cystoscopies. I gather from the conference call that it will be about 3 months for the new guidelines to be made public.
Do you think PEB would be told in advance of the decision before being made public?
Quote from: Shareguy on Jan 14, 2025, 11:14 AMFB latest note not very positive and no longer offering a target price. I note that FB own a significant amount of shares on behalf of investors as at last annual report.
I hear Forsyth Barr stuffed as many as they could into client accounts for which they had full management discretion rather than carry the baby themselves on the underwriting. Still happy to collect the full underwriting fees though. FB have been repeat "enablers" of the capital destruction that's occurred here. I hope it works out for shareholders. It's refreshing to see FB no longer have a price target. Hopefully that's a forerunner of them refusing to be an enabler for further capital destruction if PEB want to do yet another capital raise.
CEO's salary and the number of people on over $300K are a real eye opener. Thanks for sharing.
Pacific Edge and Blis Technology both out of Otago Uni ......hmmmm
Should have a course on commercialization
Quote from: Greekwatchdog on Jan 14, 2025, 01:48 PMDo you think PEB would be told in advance of the decision before being made public?
Not sure of the protocol to be honest - will try and find out - but I suspect a draft would be sent to all the relevant parties for comment and input before the decision goes public.
The Novitas decision is a setback for sure, but the pivotal moment for PEB is the AUA guidelines. Get included in that then the Novitas decision looks indefensible and would most likely be reversed on appeal. And the likelihood would be that other insurance providers would start to come on board. Then it really would be game on.
But getting blanked by the AUA (who have been fully supportive to date) would just about be a mortal blow for PEB. It would no doubt struggle on but the SP would collapse further, a capital raise would be needed and institutional support might vanish. The stakes couldn't be higher.
Quote from: Shareguy on Jan 14, 2025, 11:14 AMIs it even worth 5 cents for "a punt" which is all it is. I don't think so. If I was interested I would wait for the upcoming review, if it's negative I reckon it's all over as far as a reversal of the Novitas decision.
If wait for the upcoming review and it's positive. Will it be a missed opportunity at 5 cents and the share price take off?
Quote from: SuperMario on Jan 17, 2025, 06:18 PMIf wait for the upcoming review and it's positive. Will it be a missed opportunity at 5 cents and the share price take off?
Yes if it's positive. However the facts are that PEB have not got the study's to support inclusion according to Novitas.
In conclusion, the Cxbladder line of tests all suffer from insufficient test validation, a foundational problem in which potentially confounding clinical circumstances include non-TCC neoplasms and malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including a foundational study from Holyoake in 2008 that only used Japanese patients from one location. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers, particularly when there are issues not discussed in Pacific Edge Diagnostic funded papers that are subsequently addressed by non-funded studies, such as the 2019 Davidson study which identified increased false positives in patients with non-TCC malignancies. As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and therefore, are not payable.'
Quote from: Shareguy on Jan 18, 2025, 11:05 AMYes if it's positive. However the facts are that PEB have not got the study's to support inclusion according to Novitas.
In conclusion, the Cxbladder line of tests all suffer from insufficient test validation, a foundational problem in which potentially confounding clinical circumstances include non-TCC neoplasms and malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including a foundational study from Holyoake in 2008 that only used Japanese patients from one location. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers, particularly when there are issues not discussed in Pacific Edge Diagnostic funded papers that are subsequently addressed by non-funded studies, such as the 2019 Davidson study which identified increased false positives in patients with non-TCC malignancies. As a result, CxBladder tests are not reasonable and necessary to support positive outcomes in the management of bladder cancer, and therefore, are not payable.'
Actually in terms of clinical trials, the evidence supports CXBladders inclusion, not exclusion. This is where the Novitas decision is very shaky and vulnerable to challenge. As PEB have pointed out, Novitas have rather bizarrely chosen to ignore the 2024 STRATA study which is the most recent, comprehensive clinical utility trial and the first ever randomised controlled trial of a urine biomarker for haematuria evaluation.
Instead Novitas refer back to 2008 and 2019 studies, which were very limited and have been subsequently superseded by further clinical trials. The results of the STRATA study is one of the reasons the AUA - the governing expert body - has been supportive of PEB in its submissions. Yet Novitas didn't even refer to the STRATA study in their reasoning.
If the AUA go one step further and include CXBLadder in their official practice guidelines, you have to wonder how Novitas could continue to ignore both the clinical evidence as well as day-to-day use by urologists. It would be like saying we are right and everyone else is wrong including the clinical experts and practitioners.
Quote from: LoungeLizard on Jan 18, 2025, 12:02 PMthe 2024 STRATA study which is the most recent, comprehensive clinical utility trial and the first ever randomised controlled trial of a urine biomarker for haematuria evaluation.
Was this study funded by Pacific Edge or independent?-----------------------
Found the answer :)
It was funded by Pacific Edge. https://www.auajournals.org/doi/10.1097/JU.0000000000003991
"Funding/Support: Pacific Edge Ltd."
Quote from: SuperMario on Jan 20, 2025, 01:44 AMWas this study funded by Pacific Edge or independent?
-----------------------
Found the answer :)
It was funded by Pacific Edge. https://www.auajournals.org/doi/10.1097/JU.0000000000003991
"Funding/Support: Pacific Edge Ltd."
True, but trials for new products/tests are most often funded by the company itself, so I don't understand why Novitas seems to be critical of that fact. The study is peered reviewed and published in the AUA journal. I mean, are Novitas implying that just because PEB had to fund the trial then somehow the results are not worthy of consideration, or worse, tainted? The AUA itself would beg to differ.
Quote from: LoungeLizard on Jan 20, 2025, 09:31 AMTrue, but trials for new products/tests are most often funded by the company itself, so I don't understand why Novitas seems to be critical of that fact. The study is peered reviewed and published in the AUA journal. I mean, are Novitas implying that just because PEB had to fund the trial then somehow the results are not worthy of consideration, or worse, tainted? The AUA itself would beg to differ.
I was just about say something similar but you beat me to it. Clinical trials are expensive and I'm not familiar with any or many studies conducted by third parties at their cost.....why would they? That's not say there are none but I imagine there are not many 'fairy godmothers' out there paying to test others products. So long as the clinical trial follows a rigorous process and is peer reviewed then I have less of an issue with who funded it.
The post-decision update from PEB says that Novitas didn't even consider the STRATA trial when making their determination. This looked to be the case when I read the finalised LCD. Novitas seemed to place their decision on a 2008 study by Holyoake which is not even specific to CXBladder and about biomarkers in general. A lot of water under the bride in the 17 years since then. It really does look like a highly uninformed decision by Novitas
This from the other side. Posted by Psychic
Study Cx Bladder Monitor - good result and recommendation from over the ditch.
https://bjui-journals.onlinelibrary.wiley.com/doi/pdf/10.1002/bco2.468
Quote from: Greekwatchdog on Jan 21, 2025, 10:23 AMThis from the other side. Posted by Psychic
Study Cx Bladder Monitor - good result and recommendation from over the ditch.
https://bjui-journals.onlinelibrary.wiley.com/doi/pdf/10.1002/bco2.468
Thanks for posting.....market seems to like the news so far today!
Small sample size a possible negative.....although a reputable organisation behind the research... and not funded by PEB!
PEB's legal case seems very strong.....inclusion in the AUA's new guidelines is likely the next boost needed to trigger a successful legal challenge.
( Caveat... not a share for the faint hearted.)
3rd Quarter Update
https://api.nzx.com/public/announcement/445506/attachment/436106/445506-436106.pdf
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces tests processed at its laboratories in the three months to the end of December 2024 (Q3 25) were steady on the prior quarter (Q2 25).
Novitas' deliberations remained the overriding challenge to test volume growth, although the seasonal holiday slowdown also impacted volumes in the quarter. Against this, the addition of one FTE to the US sales team for the last month of the period, steady demand from our US customer Kaiser Permanente, the sustained benefits of our sales force efficiency gains, and an uplift in demand from the US clinicians most supportive of our tests diluted the impact of these factors.
Total laboratory throughput (TLT) in Q3 25 rose 0.7% to 7,092 tests from 7,042 tests in Q2 251. US TLT was 5,808 tests up 2.2% on the 5,682 in Q2 25. Our sales force efficiency metric was 379 tests per sales FTE, flat on the prior quarter.
Tests per unique US ordering clinician (our preferred metric for measuring customer commitment to Cxbladder) was up 9.1% in Q3 25 to 7.0 compared to 6.4 in Q2 25, while unique ordering clinicians in the quarter fell to 834 down from 890 in Q2 25.
These trends reflect the ongoing impact of Medicare uncertainty and the sales force efforts to maximise demand from Cxbladder's strongest supporters. Asia Pacific volumes were down 5.6% to 1,284 tests from 1,360 in Q2 25, a move that largely reflected the seasonal holiday slowdown in New Zealand.
The Q3 25 investor update also provides a detailed analysis of the finalized 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination released on Thursday 9 January, and Pacific Edge's response to it including:
1. Our determination to pursue a preliminary injunction if our efforts to negotiate a withdrawal or revision to the finalized LCD prove unsuccessful
2. The path the company has set to regaining reimbursement certainty and our confidence of achieving that goal
We also highlight the recent successes we have had contracting with the BlueCross Blue Shield network of health insurers to make our tests 'in-network, creating a new non-Medicare revenue stream in the US.
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
A continuation of the holding pattern that PEB have been in ever since the initial Novitas decision. Management can't really do any more than they are already doing - have the decision independently reviewed, continue working with Novitas and the AUA, prepare to file an injunction and then very possibly make a legal challenge.
Incredibly damaging and destabilising for the company.They must be tearing their hair out wondering what more they can do to get Novitas to see reason. An envelope stuffed with cash perhaps?
It is incredible that Novitas published their latest decision without reviewing the results of the STRATA study, which they originally agreed to include.
This omission, plus hopefully, the inclusion of CxBladder in the AUA Standard of Care Guidelines, must surely provide PEB with a reasonable basis for a further reconsideration of their case for reimbursement by CMS.
In addition, the existing support of Kaiser Permanante and now Blue Cross Blue Shield adds further weight to PEB's case.
All is far from lost, but the time required to reach a successful outcome is a big issue. Maybe a phone call to RFK in his new role in the Trump circus might be a worthwhile investment?
https://stockhead.cmail19.com/t/d-l-sjjtug-yupddjlly-i/
This mornings announcement
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) advises the date at which the 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination (LCD) comes into effect has been extended by two months until Thursday 24 April 2025 (US time) from the original date of Sunday 23 February (US time).
The change in effective date was observed on Sunday morning NZT after an off-schedule update to the Medicare Coverage Database overnight. The update contains no explanation, but follows representations by Pacific Edge to Novitas, its parent company GuideWell, the Centers for Medicare & Medicaid Services (CMS), the US Department of Health and Human Services Office of the General Counsel (OGC), and incoming political leadership to have the LCD revised or withdrawn.Pacific Edge will update shareholders as more information comes to hand.
What a weird outfit that Novitas appears to be.
They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.
While this hopefully may signal good news for PEB, it's a pretty strange way of doing business.
Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?
Quote from: Pierre on Jan 27, 2025, 10:00 AMWhat a weird outfit that Novitas appears to be.
They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.
While this hopefully may signal good news for PEB, it's a pretty strange way of doing business.
Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?
I suspect this extension is due to the fear of well founded legal action by PEB.
Quote from: Pierre on Jan 27, 2025, 10:00 AMWhat a weird outfit that Novitas appears to be.
They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.
While this may hopefully signal good news for PEB, it's a pretty strange way of doing business.
Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?
Yes, their decision making process looks amateurish but there are lives at stake in what they do.
I agree with LF that PEB's application for an injunction together with the threat of an independent review and/or legal action, might have Novitas running scared. Their decision making clearly doesn't make any sense and they would have a hard time justifying it in court. Getting the Department of Health involved again might also be putting them under pressure, considering it was the DOH who were critical of the process surrounding their initial decision to withdraw coverage.
Who knows what will happen in two months time???
Some more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1
Suggests the delay is driven by another company, Interepace.
Quote from: Magic78 on Jan 28, 2025, 07:13 AMSome more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1
Suggests the delay is driven by another company, Interepace.
[/quotQuote from: Magic78 on Jan 28, 2025, 07:13 AMSome more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1
Suggests the delay is driven by another company, Interepace.
Very interesting.
I see this as being a good thing as clearly other companies trying to get coverage for their products (in this case in detecting pancreatic cancer) are also being affected and are putting pressure on Novitas as well. And the fact that CMS and Novitas are now having to consider whether the proposed LCD is going to get the support of the Trump administration is also a good sign, I think. RFK jr is known to be critical of the high cost of health in the US (and it's resistance to new ideas) so maybe he could turn out to be the white knight that saves PEB. :-\
Senate just voted in RFK to HHS Secretary. This is good news IMO as the administration is sick of these high costs in the sector.
I guess time will tell. Meanwhile we wait on AUA to address guidline inclusion.
PEB's rebuttal to Medicare LCD Evidence:
https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6 (https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6)
Quote from: LoungeLizard on Feb 20, 2025, 12:09 PMPEB's rebuttal to Medicare LCD Evidence:
https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6 (https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6)
Certainly is, ultimately they need the AUA to include in the Guidelines then there is no argument.
Finally
Cxbladder Incorporated into AUA Clinical Guideline
https://www.nzx.com/announcements/447596
Now Novitas
Quote from: Greekwatchdog on Feb 28, 2025, 09:35 AMFinally
Cxbladder Incorporated into AUA Clinical Guideline
https://www.nzx.com/announcements/447596
Now Novitas
Really good news for PEB and investors - may prove to be a pivotal moment for the company as CXBladder becomes part of established procedure for all clinicians.
Logically, Novitas should now withdraw the LCD and resume coverage. This decision from the AUA blows away Novitas's claim that there isn't sufficient clinical evidence to support CXBladder or that it is not clinically of benefit to patients. But of course, it has been clear for a while that Novitas aren't making their decisions based on logic.
Revenue should increase in the meantime regardless:
"Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria."
Finally, something for investors to cheer about!
Quote from: LoungeLizard on Feb 28, 2025, 09:48 AMReally good news for PEB and investors - may prove to be a pivotal moment for the company as CXBladder becomes part of established procedure for all clinicians.
Logically, Novitas should now withdraw the LCD and resume coverage. This decision from the AUA blows away Novitas's claim that there isn't sufficient clinical evidence to support CXBladder or that it is not clinically of benefit to patients. But of course, it has been clear for a while that Novitas aren't making their decisions based on logic.
Revenue should increase in the meantime regardless:
"Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria."
Finally, something for investors to cheer about!
Opening action should be interesting, then so will the Aussie reaction at opening
Yeehah!
SP up 135% - not a bad day at the office!
Today's decision makes one wonder where the SP may go when or if Novitas finally do the right thing and re-instate coverage. Back in the good old days, before the Novitas mess and Covid, the SP was up in the $1.50's. Arguably the company is in better shape in terms of product development and exposure now, so one would think $1.50 could again be achievable. But, having been bitten badly over the last few years, I suspect investors will want to see the financials improve first, particularly becoming cash flow positive.
And on that, if Novitas do come to the party, then a capital raise would probably immediately be called, to ride the wave of optimism and to scale the orgainisation back up again.
Hopefully todays decision may get a few institutional investors interested and we may see the SP continue to climb!
Great news for holders.....
AUA guidelines inclusion gives PEB the upper hand in any further negotiations (or legal action) with Novitas IMHO.
Onwards and upwards at long last!
Cxbladder Incorporated into AUA Clinical Guideline
New AUA microhematuria guideline incorporates language for urine-based biomarkers in appropriately counseled intermediate-risk patients
Guideline specifically mentions Cxbladder Triage as the only urine biomarker with 'Grade A' evidence
Intermediate-risk patients represent an estimated 70%2 of those presenting with microhematuria
Dear Shareholder,
Pacific Edge today announces the American Urological Association (AUA) has included Cxbladder Triage as the standard of care in an amendment to its clinical guideline for the management of patients presenting with microhematuria.3
In a major amendment to the 2020 AUA microhematuria guideline4, the Panel has incorporated language for the use of urine-based biomarkers for intermediate-risk patients. It specifically mentions Cxbladder Triage as the only urine-based biomarker test that has 'Grade A' evidence from a randomized controlled trial (the STRATA Study5) in support of this recommendation. Intermediate-risk patients represent a large cohort (estimated at 70%) of microhematuria patients, and future evidence being generated in Pacific Edge's CREDIBLE Study for the next generation test Triage Plus is designed to apply beyond the intermediate-risk hematuria patients.
The guideline states: "In appropriately counseled intermediate-risk patients who want to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians may offer urine cytology or validated urine-based tumor markers (Table 5 included in this release) to facilitate the decision regarding utility of cystoscopy. Renal and bladder ultrasound should still be performed in these cases."
The AUA amendment specifically references the latest evidence generated from the STRATA Study following its publication in the Journal of Urology in May 2024. The study demonstrated in a randomized controlled trial, a first for any urine biomarker, that Cxbladder Triage could safely and effectively reduce cystoscopies by as much as 59% without missing tumors. This result paves the way for future Cxbladder products such as Cxbladder Triage Plus to be demonstrate equivalent or better performance than Cxbladder Triage for future guideline acceptance.
As a consequence of the new guideline, Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria.
Pacific Edge also expects to leverage the guideline language in its ongoing policy dialogue with Medicare Administrative Contractor Novitas and the Centers for Medicare and Medicaid services over the 'Genetic Testing in Oncology: Specific Tests' (L39365) local coverage determination (LCD). The LCD released on 9 January 2025 threatens to end Medicare coverage of Cxbladder on 24 April 2025.
Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining coverage. Pacific Edge will inform Novitas of the new guideline and expects to use the AUA guideline and the evidence on which it is based for a formal reconsideration of the LCD.
Pacific Edge Chief Medical Officer Dr Tamer Aboushwareb said: "The inclusion of Cxbladder Triage in the AUA guideline for the management of microhematuria is a significant milestone for Pacific Edge. While the guideline does not mandate the use of Cxbladder Triage, they are authoritative, reinforcing best practice within the urological industry and supporting greater adoption of Cxbladder in hematuria evaluation.
"Cxbladder is the only test supported by a Grade A evidence from the AUA Guideline panel and the update reflects the strength of the evidence supporting Triage and will help to reduce the burden of unnecessary cystoscopies in patients of lower risk, resulting in less patient discomfort and less morbidity, and improved access to care by reducing wait times," Dr Aboushwareb said.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that Cxbladder Triage has been acknowledged with its inclusion in the AUA guideline. This is an outstanding result for patients across the US, and a reflection of the role genomic tests now play in the standard of care for bladder cancer patients as they have already done for prostate, breast, colon and other cancers.
"Importantly, while the AUA Guideline language is currently focused on Cxbladder Triage for intermediate-risk microhematuria patients, we now have a strong foundation for the future inclusion of Cxbladder Triage Plus for a wider range of patient types given its superior performance characteristics6. Additionally, any competing product or service will have to complete their own randomized clinical trial to establish the same Grade A evidence, fortifying our first-mover advantage."
Dr Meintjes concluded: "The acknowledgement of Cxbladder in the AUA guideline reinforces how we create value for investors, i.e. with the continued commitment to generating the highest quality clinical evidence within a framework of AV, CV and CU, and with the appropriate end points and statistically significant sample sizes. Importantly, creating value for investors through evidence development is a core expertise that Pacific Edge can repeat for Cxbladder Triage Plus, for Monitor Plus and products beyond bladder cancer."
The AUA guidelines inclusion certainly gives Novitas a face-saving way of reversing their LCD position.
Let's hope they act quickly and make the call before the April implementation date of their current decision.
Then it definitely will be onwards and upwards for PEB as both the AUA inclusion and a positive LCD outcome will be influential in many other countries as well as in the US.
Well thats was a good day not withstanding Novitas pending decision. Timing was pretty good by AUA. I would think if Novitas say no again PEB would have good grounds to go via the courts..
This should open up alot more doors in the US now, I am interested in where John Hopkins is with their analysis since they started trialing this late 2019, mind you Covid hit so they could have slowed things down.
Anyway congrats to those fellow shareholders that sucked the last 2.5 years up
Email from PEB today. More evidence of strong indiustry support and further undermining Novitas decision
Dear Shareholder,
The inclusion of Cxbladder Triage in a February 2025 amendment to the American Urology Association (AUA) Microhematuria Guideline is set to headline a symposium at the Annual Meeting of the Southeastern Section of the AUA (SESAUA) to be held 12-15 March in Nashville, Tennessee.
The SESAUA Meeting is attended by several hundred urologists and is the first opportunity for Pacific Edge to promote Cxbladder Triage since its inclusion in the AUA Microhematuria Guideline. Cxbladder Triage will headline a symposium focused on the use of Triage to risk stratify patients with microhematuria in line with the new AUA guideline2.
In a major amendment to the 2020 microhematuria guideline, the updated guideline now incorporates language for the use of urine-based biomarkers to help avoid cystoscopy in intermediate-risk patients3. In support of this, the guideline specifically mentions Cxbladder Triage as the only urine-based biomarker test underpinned by 'Grade A' evidence linked to a randomized controlled trial - the STRATA4 Study. The STRATA study demonstrated a first for any urine biomarker, that Cxbladder Triage could safely and effectively reduce cystoscopies by as much as 59% without missing tumors.
With the guideline inclusion and symposium providing a focal point for discussion at the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.
The SESAUA symposium will be presented by Dr Zachary Klaassen, Urologic Oncologist and Associate Professor of Urology; Wellstar MCG Health and the Georgia Cancer Center.
12:15 to 1:15 PM, Thursday 13 March (CDT): Cxbladder Triage: Risk Stratification for Patients with Microhematuria (Grand Hyatt, Summit Ballroom AB)
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are excited by the opportunity to promote Cxbladder Triage to urological teams from across the Southeastern Region and the wider US with the support of AUA guideline inclusion language. Importantly the updated recommendation will benefit patients, reducing the burden of unnecessary cystoscopies for those with lower risk, resulting in less patient discomfort and morbidity. Those at higher risk will benefit from improved access to care through reduced waiting times.
"While the guideline does not mandate the use of Cxbladder Triage, it is authoritative, reinforcing best practice within the urological industry. As a consequence, Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians begin to observe this new recommendation and incorporate the tests into care pathways."
This is cool but what is happening with Novitas? Are PEB taking legal action? I don't find the previous update of 'ongoing dialogue' particularly reassuring given Novitas have so far ignored what appears to be common sense. Medicare coverage gone in 6 weeks unless something happens prior...
Quote from: raW tent Buffer on Mar 11, 2025, 01:07 PMThis is cool but what is happening with Novitas? Are PEB taking legal action? I don't find the previous update of 'ongoing dialogue' particularly reassuring given Novitas have so far ignored what appears to be common sense. Medicare coverage gone in 6 weeks unless something happens prior...
I suspect there is a lot of things going on behind the scenes with Novitas, the AUA and PEB, that we are not privy too.
You're right though, that Novitas seem to be a law unto themselves and ignore medical evidence and industry submissions. No-one really knows which way they are going to jump.
I would say though, that if they do rescind coverage in 6 weeks, then that is when PEB will launch legal action. PEB have already put out into the public domain that a legal challenge is one of their options and Novita's legal team must be aware - and should be advising Management - that they have a very strong chance of losing in court if it comes to that. But neither PEB or shareholders want to go through a messy, long and expensive legal challenge so that's why I think they are holding off until the final decision comes through.
Not long now!
Thanks LL, do you have any idea what would happen with coverage whilst legal proceedings were ongoing?
Quote from: raW tent Buffer on Mar 11, 2025, 01:27 PMThanks LL, do you have any idea what would happen with coverage whilst legal proceedings were ongoing?
Very good point - answer is, don't know. I think they would apply for an interim injunction on the decision ( ie for the affect of that decision to be suspended and coverage to continue until the court decides) but that's one for the legal boffins out there. Anyone?
Posted by Psychic on the other site..
4 weeks to go before Novitas decide as the evidence continues to come in
Independent study Monitor and Triage just published:
https://www.tandfonline.com/doi/pdf/10.2147/RRU.S516994
Results: A combined 236 patients were recruited (CxbT = 134, CxbM = 102) with results showing excellent negative predictive value
of 96.43% and 95.16%, respectively. A key result showed that CxbT in combination with upper tract imaging done as routine was able
to rule out UC completely in low-risk patients.
Conclusion: We have validated the use of Cxbladder as an adjunct in the investigation and surveillance of UC. It is a non-invasive,
accurate and reproducible test that can aid in ruling out UC, specifically for low-risk patients
Mixed update from PEB..... USA news of increased tests in 4 QTR encouraging.... but overall tests down for the year?
https://www.nzx.com/announcements/449639
Quote from: Left Field on Apr 04, 2025, 10:34 AMMixed update from PEB..... USA news encouraging.... but overall tests down?
https://www.nzx.com/announcements/449639
But headline says UP
Cxbladder Volumes Rise and Key Metrics Improve
Quote from: Left Field on Apr 04, 2025, 10:34 AMMixed update from PEB..... USA news of increased tests in 4 QTR encouraging.... but overall tests down for the year?
It's the US market - and the Novitas decision - that really matters. Fingers crossed for some positive news this month on the LCD outcome.
If reimbursement continues past 24 April, then it's up, up and away.
Quote from: winner (n) on Apr 04, 2025, 10:51 AMBut headline says UP
Cxbladder Volumes Rise and Key Metrics Improve
You missed the key point in the headline from your quote.
It actually reads:
Q4 25 Cxbladder Volumes Rise and Key Metrics Improve
Here are a couple of interesting quotes from today's PEB Investor Update relating to the recent inclusion of CxB in the AUA guidelines:
"The biggest short-term opportunity is to leverage the guideline language in our ongoing policy dialogue and legal action with Novitas and our engagement with the Centers for Medicare and Medicaid Services (CMS) over the adverse 'Genetic Testing in Oncology: Specific Tests' (L39365) local coverage determination (LCD)"
It confirms that PEB is engaged in some kind of (unspecified) legal action with Novitas. Hopefully, this will result in continuance of coverage for CMS reimbursement.
While continued CMS coverage is the desired outcome, PEB expects testing volumes and revenue to increase (though obviously at a lower rate) regardless of the Novitas outcome.
"From a business perspective, the guideline is a substantial strategic milestone on which to build our commercial operations. We expect the guideline to catalyze increased testing volume and revenue despite coverage uncertainty. Similarly, we expect this to drive medical policy and commercial contracting conversations with the vast number of healthcare plans in the US such as those with Blue Cross Blue Shield.."
Quote from: Pierre on Apr 04, 2025, 11:27 AMYou missed the key point in the headline from your quote.
It actually reads:
Q4 25 Cxbladder Volumes Rise and Key Metrics Improve
It's up 5% year-on-year - compare total 7577 in Q4 25 to 7201 tests in Q4 24 (https://www.nzx.com/announcements/429248).
In the past they did mention YoY (e.g. Q3 23 (https://www.nzx.com/announcements/405516)), along with mumbling about seasonal variations to explain QoQ. Now we just get the mumbling.
Disc: Holding and expecting better
Posted by Psychic on the other site
PE/ Kaiser study results published for Cxbladder Triage.
https://www.auajournals.org/doi/abs/...88.99555.df.11
RESULTS:
Rates of cystoscopy were much lower (3.9%) in those with a low-risk Triage result compared to their matched comparison group without a test (42.5%), while those whose Triage result recommended physician-directed protocol had a much higher rate (72.9%) than their matched comparison group (41.4%).
CONCLUSIONS:
These data reveal that CxBladder Triage testing resulted in significantly decreased cystoscopy and imaging utilization in those classified as low risk, while simultaneously demonstrating increases in the cystoscopy and bladder cancer detection rate in the physician directed protocol group. Further systematic evaluations of the Triage test are warranted to reduce the burden of unnecessary cystoscopy.
Posted by Psychic on the other site
https://scholar.google.co.nz/scholar...&pos=0&folt=kw
PE funded Cxbladder Monitor study results
Results: Compared with SOC, CxbM reduced mean total costs by $68,621 for 100
patients over 5 years or $137.24 per patient per year. Cystoscopy was reduced by
129 (0.31 per patient per year), and there was no difference in delayed cancer
diagnosis. Using a probabilistic model, the median cost reduction per patient per
year was $160 (95% credible interval 520 to 109) with 86.2% probability of cost
savings.
Conclusions: In this Markov model, incorporation of CxbM into surveillance for
NMIBC reduced cystoscopy without negative impact on cancer detection with
cost savings for the majority of simulations run.
Quote from: Greekwatchdog on Apr 15, 2025, 11:22 AMPosted by Psychic on the other site
PE/ Kaiser study results published for Cxbladder Triage.
https://www.auajournals.org/doi/abs/...88.99555.df.11
RESULTS:
Rates of cystoscopy were much lower (3.9%) in those with a low-risk Triage result compared to their matched comparison group without a test (42.5%), while those whose Triage result recommended physician-directed protocol had a much higher rate (72.9%) than their matched comparison group (41.4%).
CONCLUSIONS:
These data reveal that CxBladder Triage testing resulted in significantly decreased cystoscopy and imaging utilization in those classified as low risk, while simultaneously demonstrating increases in the cystoscopy and bladder cancer detection rate in the physician directed protocol group. Further systematic evaluations of the Triage test are warranted to reduce the burden of unnecessary cystoscopy.
What is very important in this study is n=2754. That is a very significant sample size.
PEB to feature at the next AUA conference April 26 to 29..... ( interesting as this timing follows the due date for the expected decision from Novitas of 24 April 2025 (US Time) )
Release from PEB today.
Cxbladder's Clinical Utility in Focus at AUA 2025
Recognition of Cxbladder's clinical and economic value in evaluating patients presenting with hematuria is set to gain momentum at the American Urological Association's (AUA) Annual Meeting, April 26–29 in Las Vegas.
A plenary session at the meeting will highlight Cxbladder Triage's inclusion in the AUA's new microhematuria guideline released in February 2025. Additional sessions will cover a large real-world study by Kaiser Permanente2 confirming the clinical utility of Triage, and preliminary results3 from the DRIVE study focused on the clinical validation of Triage Plus.
These sessions are a significant opportunity for Pacific Edge to deepen market understanding of Cxbladder's performance and drive its broader clinical adoption.Pacific Edge Chief Executive Dr Peter Meintjes said: "Guideline amendments are always significant talking points at an AUA meeting. However, with urine biomarkers getting their first positive inclusion language in the microhematuria guideline4 and Cxbladder Triage being the first and only biomarker to receive a 'Grade A'5 evidence, this year is bigger than most, and the plenary session provides a great platform for how Pacific Edge is improving the standard of patient care.
"The Kaiser Permanente study is important because it demonstrates the real-world impact of Cxbladder Triage with tremendous statistical power given the sample size of 3,353 patients. The design of the study prospectively managed hematuria patients according to the new Triage-based standard of care and then retrospectively compared those clinical outcomes to a cohort of "risk-matched" patients from Kaiser Permanente nation-wide EMR who did not. This kind of study and evidence generation is uniquely available in the Kaiser Permanente system and underscores the value of our partnership and our shared commitment to improving patient outcomes.
"The DRIVE study will be presented in the Urological Society of American Veterans (USAV) session at the AUA to showcase preliminary clinical validity results for Triage Plus for the evaluation of hematuria in a Veterans population. These data are important for establishing a local coverage determination for Triage Plus with Novitas, and as validation for the US Veterans Administration to consider incorporating Cxbladder into its facilities."
Interesting, if not a little frustrating if Novitas say no
Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes the US District Court for the Middle District of Pennsylvania has determined that it does not have jurisdiction to conduct judicial review of 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination.The judgment means the court is not able to consider the merits of Pacific Edge's legal complaint filed in the US District Court on 19 February 2025 about the LCD, despite Judge Neary noting in her ruling that "the company has also marshalled incredibly compelling facts for why its test is a medical marvel."The judgment was published around 4:15pm ET on 23 April 2025 and means the remaining avenue for L39365 not to become effective on 24 April 2025 in the USA is a policy action by the Center of Medicare and Medicaid Services (CMS).CMS has the authority to unilaterally extend the effective date of L39365 independent of the Court's ruling. Pacific Edge and associated parties have made the case for retirement of the LCD or extension of the effective date to the incoming political appointees within CMS , HHS and OGC . Pacific Edge is continuing to watch closely to determine what action, if any, CMS will take and we will update the market as we receive further information.
Is anyone able to comment on what this ruling means for PEB in terms of legal recourse against the LCD.
In declining jurisdiction, has the District Court effectively said that there is no route for a legal challenge in any court?
Or is it now a matter of re-filing in a court that does have jurisdiction?
Mmmmm the rationale, expense and legal advice as to why PEB chose to file this action with a Middle District court in Pennsylvania needs to be reviewed. Clearly not the right course of action.
However the judges unprompted opinion that "the company has also marshalled incredibly compelling facts for why its test is a medical marvel" is encouraging for further legal action if needed.
Meanwhile investors wait for an update on Novitas's decision due tomorrow 24 April (US time.)
ps Poet - I think your last point regarding re-filing is the correct possible future action for PEB ..... but only if tomorrow's Novitas possible decision is unfavourable.
Not sure why but PEB have not been very transparent about their legal challenge to the LCD. You would have thought if there was another route to challenge this legally they would have mentioned it in that announcement. Sounds like they're just hoping for CMS to come to the rescue at the 11th hour.
It's not looking good brev
It's not looking good brev
[/quote]
The fact its in the AUA guidelines is a total game changer.
Whilst they don't have to use it, they are advised to follow best practice.
If they say no it goes against the AUA and all the other evidence been presented.
I think they ask for another extension.
The LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?
I hope they extend it but there's nothing about Novitas that fills me with optimism.
Quote from: raW tent Buffer on Apr 24, 2025, 11:41 AMThe LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?
I hope they extend it but there's nothing about Novitas that fills me with optimism.
Novitas might have been waiting for the outcome of the court case before jumping one way or another. I think the court's comment re 'compelling facts' and 'medical marvel' give a clear steer on what ruling would be forthcoming if they manage to get the case in front of a court that does have jurisdiction.
Quote from: raW tent Buffer on Apr 24, 2025, 11:41 AMThe LCD goes into effect tomorrow. The last extension was made more than 3 weeks prior to the implementation date. Don't you think Novitas have left it a bit late if they were going to extend it?
I hope they extend it but there's nothing about Novitas that fills me with optimism.
Honestly who would know. I mean the AUA inclusion in guidelines was such a feat saying no is dumb arse move given the positives to the patient and payer. Hey its the US and the land of stupidity
Quote from: raW tent Buffer on Apr 24, 2025, 12:07 PMyeah exactly. they could (and should imo) have turned round and reversed the LCD immediately after the AUA inclusion, there's been no reason to delay til now to do it, hence I feel it's unlikely they will do anything tomorrow and the LCD will come into effect. who knows though.
fingers crossed because it's a product that helps people with a horrible disease and it works.
Tim Hunter in NBR has some interesting comments from PEB and some background to court decision
https://www.nbr.co.nz/investment/us-court-declines-to-intervene-in-pacific-edge-funding-crisis/
In short
PEB still hopeful that decision will be positive and Novitas rescinded an order within a couple of hours of implementation deadline just recently
There are avenues for appeal once a negative decision takes effect
PEB has some political support and lobbying in place
Agree with comments that this isn't the end of the road for PEB even if Novitas stick with the LCD. The District court although conceding it doesn't have the authority to hear the case has made it clear that PEB have a compelling product and implies that appealing to another jurisdiction that does have authority may well be successful. And of course CMS could extend the coverage again or even instruct Novitas to rescind the LCD. Or Novitas may finally see sense and rescind the LCD itself, although it is cutting it fine if it is going to do that. So many scenarios that have yet to be played out. Meanwhile the real world evidence of CXBladder's positive impact on patient care and diagnosis continues to stack up and further endorsement from the AUA is likely.
A piece out of Herald tonight..
Pacific Edge also had a lot of movement today, with its share price falling by 7.32% to $0.11, with 257,628 shares trading hands to the value of $30,423.60.
Goodson said the market will be looking to the decision out tomorrow on whether Pacific Edge will lose coverage under Medicare and Medicaid in the US.
"That would be a ludicrous outcome, because they've been included in the American Neurological Association guidelines with quite helpful wording.
"We don't know if they'll lose coverage or whether CMS [Centres for Medicare and Medicaid Services] has been waiting for the outcome of this court case, and the court said they lacked jurisdiction to try it."
Good Luck to all of us tomorrow. If its negative its only a setback, ultimately AUA inclusion in the guidelines speaks volumes for CXB.Product
Quote from: Greekwatchdog on Apr 24, 2025, 06:23 PMA piece out of Herald tonight..
Pacific Edge also had a lot of movement today, with its share price falling by 7.32% to $0.11, with 257,628 shares trading hands to the value of $30,423.60.
...
Good Luck to all of us tomorrow. If its negative its only a setback, ultimately AUA inclusion in the guidelines speaks volumes for CXB.Product
To be precise, it fell from $0.123 at close yesterday, to $0.114 today. NBR needs to add an extra digit to their widget. (PEB's own Investor Centre is even more misleading, showing a price of $0.110 for NZD on the NZX - although coincidentally this would be correct in AUD on the ASX.)
I don't think there's a go/no-go decision needed from CMS at this point, as the old LCD was already superseded and just counting down to the new effective date.
It's frustrating that the AUA guidelines revision already invalidated a pillar of Novitas' argument supporting the LCD, before it took effect, but to be fair those guidelines did only come out recently. Guess we'll need to be patient with the process. If a new LCD revision is what's needed to reinstate coverage, hope it doesn't take years this time around.
Meanwhile, addressable market still includes US private insurance and the rest of the planet. Medicare coverage was nice while it lasted, but hasn't been enough to turn a profit.
Disc: Faithfully holding
Posted on other channel.
Not good news!! A difficult and frustrating read......
https://www.cms.gov/medicare-coverag...relevance&bc=1
Thanks for posting
The above link didn't work for me..... but this one did.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1
Yes bad news it would seem.....BUT
This sentence in the determination interested me....
"Enhanced Cxbladder Triage and Cxbladder Resolve are removed since they are not yet commercially available." ?????
Has the door been left open?
Can PEB now work to make these two tests available commercially and have them included?......... Probably way too simplistic.
PEB's response to todays news will be interesting.
From Jonu on the other side....
Extraordinary. They still don't acknowledge the AUA guidelines amendment from February, but say as of the 2024 AUA guidelines, CXBladder isn't recommended. It appears they haven't caught up with it yet. By their own logic, the decision can't hold once they incorporate the update. You have to ask the question of competency or corruption here. I hope the AUA gets stuck into them.
I expect it will be a negatively volatile period for the share price while it gets sorted, but the decision can't stand. I might look for an opportunity to accumulate if the share price plummets.
Discl;Holding
A terrible, frustrating and illogical decision from Novitas. Par for the course, unfortunately, as PEB have come up against vested interests, bureaucratic inertia and dare I say it, possible corruption. Thats the US Health system for you! The door has been left open though if the AUA get further involved and CMS do their job in making sure the system works for the patients rather than corporate interests. Will be interesting to see how PEB respond and how much of a pummelling the SP gets. A capital raise might have to be considered if lengthy legal action is taken and revenue plummets.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1
Nothing has changed in this LCD since January, the wording is identical and it's just that the date has ticked over past 24/4/2025. There has been no reference made to AUA 2025 guidelines which include the use of CXbladder in microhematuria diagnosis with a "strong" recommendation, the STRATA study or the very recent Kaiser Permanente study with a 3353 patient sample size, all of which prove the value of CXBladder in improved patient outcomes and cost reduction over present methods. It could be argued that Novitas has failed to correctly assess the clinical value of CXBladder in the light of all the current information. That may be the approach PEB uses directly with CMS. Tough times continue for those of us still keeping the faith.
Quote from: 850man on Apr 25, 2025, 09:53 AMhttps://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1
Nothing has changed in this LCD since January, the wording is identical and it's just that the date has ticked over past 24/4/2025. There has been no reference made to AUA 2025 guidelines which include the use of CXbladder in microhematuria diagnosis with a "strong" recommendation, the STRATA study or the very recent Kaiser Permanente study with a 3353 patient sample size, all of which prove the value of CXBladder in improved patient outcomes and cost reduction over present methods. It could be argued that Novitas has failed to correctly assess the clinical value of CXBladder in the light of all the current information. That may be the approach PEB uses directly with CMS. Tough times continue for those of us still keeping the faith.
Yes, Novitas seems to be almost wilfully ignoring all recent studies, real time results and the AUA's endorsement in order to stick with their original assessment. Why they are doing it, is the real question. There would be no contradiction - it would make perfect sense - for Novitas to renew coverage based on all the new evidence, but they refuse to do so. It's now up to CMS to issue Novitas with a "please explain" and if they can't do so, then formally be instructed to renew coverage.
This is going to run and run unfortunately.
Catching up on this, it was claimed back in January (see Discoveries in Health Policy coverage (https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html) and their update (https://www.discoveriesinhealthpolicy.com/2025/04/novitas-lcd-for-oncology-specific-tests.html) this week) that the reason for the LCD effective date delay was for the 'incoming Trump administration' (not CMS specifically) to review evidence for Interpace's PancraGEN tests (not CxBladder), which was also losing coverage.
For what it's worth, Trump's appointed CMS head, Dr Mehmet Oz, was only sworn in a week ago. He may've had some higher priority items on his todo list.
Was there ever an announcement that CMS was actually taking the opportunity to reconsider CxBladder coverage - other than PEB pointing out that (in theory) they could? I'm puzzled why folks were seemingly expecting CMS to step in at the 11th hour and overrule their contractor's decision.
I was also trying to find info on what proportion of PEB's tests were being reimbursed by CMS or otherwise at risk. Mostly their reporting doesn't break this out. The 2025 Q3 investor update (https://www.pacificedgedx.com/assets/Investor-Files/PEB-Quarterly-Update-Q3-25.pdf) does mention Medicare (perhaps, not including Medicare Advantage) accounts for 54% of US commercial tests. For 2023 FY (https://www.pacificedgedx.com/news-and-events/news/2023/medicare-coverage-of-cxbladder-expected-to-cease/) 60% of test volume (77.3% of revenue) was at risk from the LCD, which includes Medicare (CMS reimbursed) and Medicare Advantage (private) plans.
I'm wondering if the effect on private Medicare Advantage plans is automatic and immediate, or if United Healthcare (in particular) has to formally confirm coverage loss. Does anyone have better info on expected impact?
Also for perspective, Kaiser Permanente is a top health insurer in the US still covers CxBladder, but only has less than 10% market share (https://www.valuepenguin.com/largest-health-insurance-companies). Armed with updated AUA guidelines, PEB salesforce should have a better chance to sway other private insurers to get on board.
For Bars review
Pacific Edge (PEB) remains set to no longer receive reimbursement for its Cxbladder tests from CMS in the US. CMS has announced that it has revised its local coverage determination (LCD), with no substantial revisions of note for PEB. The revised LCD became effective on 24 April 2025 (US time). CMS represented ~60%–70% of PEB's revenue prior to the recent slowdown and remains its largest market and key growth driver. This is a big blow—but all is not necessarily lost. In light of the positive American Urological Association (AUA) guideline outcome in February 2025, and updated evidence since the initial LCD, we expect PEB to lodge a reconsideration request, which could reverse the decision. If unsuccessful, we expect ongoing clinical evidence generation investment and a further operational battening down of the hatches. We expect PEB to update the market, but near-term plans will undoubtedly involve the active pursuit of a reconsideration. With net cash of ~NZ$23m at FY25 on our estimates and cash burn of ~NZ$2m a month, timelines are tight.
A big blow (again...)
On 27 January 2025, it was announced that Novitas extended the final LCD commencement deadline by 60 days to allow for revisions. Unfortunately, the scope of revisions (which appear negligible) still means PEB's Cxbladder tests will no longer be covered by CMS. At this point, the LCD is final and became effective on 24 April 2025.
Next steps
PEB will likely update the market with its next steps. In the near term, a reconsideration request will be lodged. PEB stated in its latest quarterly update it 'will use the new guideline, and the evidence ignored by Novitas as it finalised the LCD (including the STRATA study and updated analytical validation studies of Triage and Detect)'. Novitas has not taken these updates into account, and under current legislation, Medicare contractors are required to consider guidelines in determining coverage. We see solid grounds for reconsideration, but given Novitas' behaviour over the past 33 months, this is hard to call. Medicare contractors have 60 calendar days to respond. If successful, the LCD will be reopened and a new process will commence. If unsuccessful, PEB has previously mentioned: (1) further cash burn reduction initiatives, and (2) exploring strategic alternatives. Legal action is now off the table, with the US district court unable to consider the merits of PEB's complaint. Regarding cost initiatives, we expect ongoing evidence investment as a mechanism to regain coverage and improve adoption. We forecast FY25 net cash of ~NZ$23m (NZ$28.5m at 31 December 2024). At current burn rates, this represents less than 12 months of cash on hand. Based on PEB's pre-CMS opex base, general inflation, and research cost uplift, we expect opex to fall significantly to ~NZ$34m in FY26 (from ~NZ$59m in FY24). We acknowledge there is a chance PEB could cut opex further, but suspect no decision will be made until the reconsideration outcome is delivered. Outside CMS, revenue growth has been encouraging (driven by the US), but at revenue of ~NZ$10m in FY25E (growth of ~+45%), it remains small relative to PEB's opex base and the prior CMS contribution.
Trading Halt this morning. Wonder what's up
Reason for trading halt:
Pacific Edge is aware the Centers for Medicare and Medicaid Services
(CMS) has published the draft Gapfill prices for Cxbladder Triage Plus with the median price of
US$1,018.44.
Pacific Edge is currently reviewing the prices and the associated documentation and needs time to
assess the implications of them, consult with its advisers and industry partners, and prepare an
announcement that provides context to investors.
It expects to provide an update to the market, at the latest, before the opening of trading on 30 April
2025.
Here is what PEB said in January 2025
TRIAGE PLUS COMMERCIALIZATION
The success of the negotiations with BCBSTX,
BCBSIL and Wellmark reflects the effectiveness
of clinical utility data from our STRATA study, a
prospectively enrolled randomized clinical trial that
demonstrated Cxbladder's clinical utility in helping
clinicians to safely and more effectively risk-stratify
low-risk hematuria patients when compared to
AUA guidelines. For healthcare payers, the study
highlighted the benefits of using Cxbladder to
improve patient care and optimize resource use.
CMS confirms Gapfill to price Triage Plus
The Centers for Medicare and Medicaid Services (CMS) has affirmed it will follow a Gapfill process to price
Cxbladder Triage Plus, the company's second generation Cxbladder test for hematuria evaluation. The
CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare
and Medicare Advantage insurance.
CMS agreed with the Pricing Panel that Gapfilling Triage Plus was more appropriate given its view that
there were no suitable crosswalk candidates in the current CMS Clinical Lab Fee Schedule. Gapfill requires
all Medicare Administrative Contractors to recommend an initial price each year in April, and to follow a
notice and comment process that is only finalized in late November.
We continue to focus on preparing our US laboratory for running Triage Plus at scale and will work
with Novitas on provisional pricing for Triage Plus to ensure that a Gapfill recommendation is not limiting
our ability to launch the new test with reliable reimbursement. We remain confident Triage Plus will
achieve a price that will deliver a greater margin both in nominal and percentage terms than the current
generation of products, underpinning our drive towards long-term financial sustainability
Sounds to me like they expected/wanted the amount to be higher?
Quote from: raW tent Buffer on Apr 29, 2025, 11:04 AMSounds to me like they expected/wanted the amount to be higher?
the re-imbursement price for cxbladder when it first gained coverage in 2020 was $USD760 so $US1018 for triage plus probably isn't all that disappointing.
All a bit moot though isn't it? until they can get coverage.
Quote from: raW tent Buffer on Apr 29, 2025, 11:04 AMSounds to me like they expected/wanted the amount to be higher?
Agreed, but they have a difficult path to negotiate. Too cheap isn't business-sustainable; too expensive and patients may not be prepared to pay. Never a dull moment with PEB.
Quote from: Poet on Apr 29, 2025, 11:21 AMthe re-imbursement price for cxbladder when it first gained coverage in 2020 was $USD760 so $US1018 for triage plus probably isn't all that disappointing.
All a bit moot though isn't it? until they can get coverage.
Here's what PEB were aiming for back in July 2024
"Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of
incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.
If CMS shares our view and agrees that Detect+ should attract a price of US$1,590, Pacific Edge
would gain significant upside to our existing market opportunity for hematuria evaluation." So today's $1018 price better than the $760 they were getting, but not as high as they would have liked.
Can't help thinking a reason for the trading halt maybe that PEB could be evaluating a Cap Raise to allow them to progress based on this decision etc......
Pure speculation of course.
Quote from: Left Field on Apr 29, 2025, 11:50 AMHere's what PEB were aiming for back in July 2024
"Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of
incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.
If CMS shares our view and agrees that Detect+ should attract a price of US$1,590, Pacific Edge
would gain significant upside to our existing market opportunity for hematuria evaluation."
So today's $1018 price better than the $760 they were getting, but not as high as they would have liked.
Can't help thinking a reason for the trading halt maybe that PEB could be evaluating a Cap Raise to allow them to progress based on this decision etc......
Pure speculation of course.
The tone of the release and the numbers themselves sound positive:
"Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline."
Clearly Triage Plus is the immediate focus and there is reason to be hopeful that eventually it will be covered under Medicare.
Agreed that PEB may have to do a cap raise to bridge the funding gap in the short term. I can imagine it would be well supported as I feel PEB's products are gaining traction, the Novitas decision notwithstanding.
More from PEB ..... sounding positive... (and no mention of a Cap Raise)
https://www.nzx.com/announcements/450711
Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study , has already been submitted for publication.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.
"The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics are used in our existing budget impact model we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most."
Onwards and upwards.........C'mon PEB you can do it!
I suspect there will be more details coming out at the Full Year announcement next month. Be interesting to see what PEB have to say around expenditure to preserve cash and the prospect of a CR.
Unless they some how manage to come up with a solution I think it will be inevitable that a CR is needed within 12 months
FYI posted on the other channel by 850man
Latest trial by Kaiser Permanente significantly involving 3353 patients, presented at the 2025 AUA conference. More info here:
https://www.urologytimes.com/view/cx...y-cystoscopies
Quote from: Greekwatchdog on Apr 30, 2025, 12:01 PMFYI posted on the other channel by 850man
Latest trial by Kaiser Permanente significantly involving 3353 patients, presented at the 2025 AUA conference. More info here:
https://www.urologytimes.com/view/cx...y-cystoscopies
I think this trial only needs peer review before it further adds to the evidence in favour of CXB
Results in
https://www.nzx.com/announcements/452559
Cap Raise in @ $.10 which I will participate in
PEB Accumulated losses now $276,222,000 and like any growth company still growing
Truly amazing, after shareholders have contributed $294,458,000 .....soon to be over $0.3billion
I can say such things because I contributed some of that $294m years ago and fortunately more than doubled my money
My thoughts on todays news align with Balance on the other channel......
"Real shame for NZ Inc that PEB has suffered the US setbacks.
We need companies like PEB to be successful to inspire young NZers and provide opportunities.
Been there and done that myself with PEB. Like W69, I have done very well in the past with PEB and wish them & shareholders success."
However IMO, the 19% premium being charged for this cap rise is interesting to say the least!... (10c per share v last traded at 8.4c.)
Inevitable that a CR would be required and I still believe that ultimately coverage will be reinstated. I'm surprised a little at the SPP price of 10c - above the current market price. Might not affect the big institutions much but retail investors may look to buy on-market. I will participate in one form or another and hope that in 12 months time, when coverage is re-instated, investors will (finally) get their reward. ;)
The AUA guidelines and Gap Fill pricing re Triage + must mean something and with PEB already knocking down the Novitas door I suspect they are very confident of gaining coverage soon. Who knows what other contracts with major potential clients (John Hopkins have been reviewing since late 2019) going forward...
PEB has raised $16 million at 10cps from institutional shareholders.
That should be good for some SP movement today.
Quote from: Pierre on Jun 03, 2025, 09:04 AMPEB has raised $16 million at 10cps from institutional shareholders.
That should be good for some SP movement today.
Yes, that's a good vote of confidence from the institutions. What the SP does will determine the level of participation from retail investors.
I'm not surprised that so far today PEB retail investors have been able to purchase more shares below the 10c price paid by Institutes.
Interesting also is the timing of the retail offer as outlined below.
https://www.nzx.com/announcements/452692
"Pacific Edge is now targeting the opening of a NZ$5 million offer to eligible retail investors by way of a Share Purchase Plan (SPP) at the same NZ$0.10 cents per share offer price in July or early August 2025 (with the ability to accept oversubscriptions). A shareholder meeting to approve the Placement is planned for late July or early August 2025."
Why late July or August? Perhaps PEB is hoping for good news to drive the SP north of 10c before that time?
Quote from: Left Field on Jun 03, 2025, 12:45 PMI'm not surprised that so far today PEB retail investors have been able to purchase more shares below the 10c price paid by Institutes.
Interesting also is the timing of the retail offer as outlined below.
https://www.nzx.com/announcements/452692
"Pacific Edge is now targeting the opening of a NZ$5 million offer to eligible retail investors by way of a Share Purchase Plan (SPP) at the same NZ$0.10 cents per share offer price in July or early August 2025 (with the ability to accept oversubscriptions). A shareholder meeting to approve the Placement is planned for late July or early August 2025."
Why late July or August? Perhaps PEB is hoping for good news to drive the SP north of 10c before that time?
Yes, good point regarding the long lead in time to the SPP. Bit of a gamble charging a premium to the current price, if PEB are not confident of the SP going north in the interim.
Quote from: LoungeLizard on Jun 03, 2025, 12:59 PMYes, good point regarding the long lead in time to the SPP. Bit of a gamble charging a premium to the current price, if PEB are not confident of the SP going north in the interim.
Even more of a problem if PEB regains medicaid coverage before the PEB shareholder vote on the cap raise. Institutions have committed to participating in the cap raise but need to wait for shareholder approval first (July/August). Presumably the shareholders won't vote for the cap raise if the coverage determination has come through in the meantime.
Effectively PEB have a PUT option for $16m (at 10c) for the next couple of months. An unusual situation IMO
I like this from the July Shareholder update:
On June 26, 2025 (US time) we met with Novitas6
Medical Affairs to discuss the reconsideration request we
had made for Triage in March. The conversations were
thorough and engaging, with the Novitas team noting
that they had familiarized themselves with the AUA
microhematuria guideline ahead of our call. The Novitas
team made it clear that they understood how our test
could deliver clinical utility to physicians and economic
utility to insurers and expressed their commitment to
provide medically reasonable and necessary testing
to the Medicare population. They discussed with us
the precise indications for coverage, focused on how
physicians select patients for Triage testing. The 2020
and 2025 AUA Guidelines, the Kaiser Abstract from the
AUA, and our STRATA publication clearly identify those
patient types, and Novitas gave a non-binding verbal
indication that our evidence was compelling for the
purposes of re-opening the LCD.
We have a second meeting with Novitas on July 17
to discuss the reconsideration request for Cxbladder
Monitor that we submitted in May, and we look forward to
submitting a request later this year for Medicare coverage
of Triage Plus, when the Analytical Validation (published
8 July 2025 online in Diagnostics7) and Clinical Validation
(DRIVE study, in peer review) are published. We note that
the Medicare Program Integrity Manual allows Novitas
to combine reconsideration requests together when
opening an LCD and overlapping submissions may affect
the previously estimated timelines.
Market likes the update on opening
Quote from: Greekwatchdog on Jul 14, 2025, 10:22 AMMarket likes the update on opening
Yes, it looks promising that even without coverage the numbers haven't reduced dramatically. And it does sound that Triage has a very good chance of gaining reapproval on resubmission. Coupled with the significant increase in the CMS reimbursement price to $1018 per test, I remain optimistic that shareholders will be handsomely rewarded for their (considerable) patience!
Quote from: Greekwatchdog on Jul 14, 2025, 10:22 AMMarket likes the update on opening
This is good news for the upcoming SPP too. If the SP holds around the current level, the $5 million is likely to be well oversubscribed - and they will probably take all the cash they are offered.
Just shows how little I know....... I wasn't that impressed by the update..... but the market likes it, so I'm happy.
Quote from: Left Field on Jul 14, 2025, 11:33 AMJust shows how little I know....... I wasn't that impressed by the update..... but the market likes it, so I'm happy.
I think its more to do with the commentary surrounding Novitas.
Personally I thinks its a given they regain coverage by year end, then we are dealing with Amercians...Hmm.
Novitas does seem to be strongly indicating that coverage will be reinstated in due course, however long that may be. Two very positive meetings where they seem to have finally acquainted themselves with all the evidence and AUA guidelines plus this very encouraging statement:
"...and Novitas gave a non-binding verbal indication that our evidence was compelling for the purposes of re-opening the LCD."
There's still a volume of water to pass under the bridge but I wonder if we are at the point when the stars really start to align for PEB. Time will tell, but I see this update as being very encouraging. Market seems to like it, up 10% at one point.
Quick question - I sold all my PEB shares today (pretty much break even). I used the proceeds to apply for the SPP, basically for an extra 15k shares on top of what I sold.
Are there any actual risks with this other than me being scaled down so I don't get all the shares I ask for? It seems weird to me why people are buying shares at 10.7c?
I did it with the view that they need all the cash they can get so are unlikely to turn down oversubscription so it's effectively more shares for nothing. Or am I missing something here?
Quote from: raW tent Buffer on Jul 17, 2025, 02:13 PMQuick question - I sold all my PEB shares today (pretty much break even). I used the proceeds to apply for the SPP, basically for an extra 15k shares on top of what I sold.
Are there any actual risks with this other than me being scaled down so I don't get all the shares I ask for? It seems weird to me why people are buying shares at 10.7c?
I did it with the view that they need all the cash they can get so are unlikely to turn down oversubscription so it's effectively more shares for nothing. Or am I missing something here?
Nothing wrong with that as far as I can tell, although for just an extra 15k shares I am wondering whether it is worth the effort? But you're right, I can't see them turning down oversubscription, so you should be pretty safe.
I guess people who didn't own shares at the 11 July might be buying in now at 10.7c, based on the latest announcement regarding discussions with Novitas? Although the volumes indicate that maybe the Insto's are further topping up as well.
There does seem to be a good deal of support on market and for the SPP. I think it really is a case of when, rather than if, Novitas resume coverage, in which case anyone buying in now on or off market stands to make a pretty penny.
Quote from: LoungeLizard on Jul 17, 2025, 02:44 PMNothing wrong with that as far as I can tell, although for just an extra 15k shares I am wondering whether it is worth the effort? But you're right, I can't see them turning down oversubscription, so you should be pretty safe.
I guess people who didn't own shares at the 11 July might be buying in now at 10.7c, based on the latest announcement regarding discussions with Novitas? Although the volumes indicate that maybe the Insto's are further topping up as well.
There does seem to be a good deal of support on market and for the SPP. I think it really is a case of when, rather than if, Novitas resume coverage, in which case anyone buying in now on or off market stands to make a pretty penny.
Cheers for that. It was very easy to do and yeah not much but just seemed silly not to. Interested to see where the SP goes after the placement.
I have submitted my application to add 50% assuming its accepted in full. They key for me is the inclusion of AUA guidelines as this was the main catalyst to drive commercial success including all the evidence that they are putting together via STRATA and what has already been published.
It will be an interesting ASM next week (6th Aug) By then the CR offer will have closed so perhaps we get more info on how the 2nd meeting with Novitas went and maybe more updated on new commercial contracts (John Hopkins is major one for me as its been looked at since late 2019)
As always DYOR.
Quote from: Greekwatchdog on Jul 30, 2025, 05:19 PMI have submitted my application to add 50% assuming its accepted in full. They key for me is the inclusion of AUA guidelines as this was the main catalyst to drive commercial success including all the evidence that they are putting together via STRATA and what has already been published.
It will be an interesting ASM next week (6th Aug) By then the CR offer will have closed so perhaps we get more info on how the 2nd meeting with Novitas went and maybe more updated on new commercial contracts (John Hopkins is major one for me as its been looked at since late 2019)
As always DYOR.
I've applied for another 10% - I already hold far more than is sensible!
Agreed - the potential of a major swing upwards outweighs the chances of SP falling further.
"It's worth the stretch," - as De Niro said in Heat when contemplating a bank robbery. Mind you, that didn't work out well...
Quote from: LoungeLizard on Jul 30, 2025, 06:20 PMI've applied for another 10% - I already hold far more than is sensible!
Agreed - the potential of a major swing upwards outweighs the chances of SP falling further.
"It's worth the stretch," - as De Niro said in Heat when contemplating a bank robbery. Mind you, that didn't work out well...
LOL yeah, but PEB don't have to worry about Pacino this time as they have already gone thru that and have em by the short and curlys!
Good to see the SP holding up after yesterday's retail offer deadline.
Quote from: LoungeLizard on Aug 01, 2025, 12:30 PMGood to see the SP holding up after yesterday's retail offer deadline.
It will be interesting to see how much they have raised from investors in the retail offer.
I'm not anticipating any fireworks at next Wednesday afternoon's meeting but hopefully there will be at least an update on how negotiations are going with PEB's "friends" at Novitas.
Well thats pretty good result in my book. $4.7m raised out of $5m out of retail investors
�https://www.nzx.com/announcements/456105
Job done. Now, over to PEB / Novitas to repay the faith.
Presentation details from ASM today.
Some useful progress being made despite the vagaries of USA Healthcare under R F Kennedy Jnr serving as secretary of health and human services!
https://api.nzx.com/public/announcement/456344/attachment/448912/456344-448912.pdf
Anything useful come up in today's Q & A session? ( I couldn't attend)
I think the most positive point to come from today's meeting is that it will be highly unusual for a product that is included in medical guidelines to remain excluded from Medicare coverage. The latest Novitas determination did NOT take the latest clinical evidence into account when making their decision. Peter Meintjes appears quietly confident of a successful outcome from PEB's recoverage application.
Director Anatole Masfen, whose company contributed $5 million to the latest CR, said in his opinion PEB is in the best position for success than it has ever been.
Brilliant, thanks Pierre.
Anatole Masfen is a smart investor. Fingers Crossed.
Quote from: Pierre on Aug 06, 2025, 05:19 PMI think the most positive point to come from today's meeting is that it will be highly unusual for a product that is included in medical guidelines to remain excluded from Medicare coverage. The latest Novitas determination did NOT take the latest clinical evidence into account when making their decision. Peter Meintjes appears quietly confident of a successful outcome from PEB's recoverage application.
Director Anatole Masfen, whose company contributed $5 million to the latest CR, said in his opinion PEB is in the best position for success than it has ever been.
Agreed. It does seem to be a matter of when, not if, PEB regain Medicare coverage, as the medical evidence now being considered is overwhelmingly in favour of a positive outcome. Let's hope Novitas don't take the full 12 months (and more) as they did last time, to make their decision.
ANZ still buying up large. Good sign of confidence.
https://www.nzx.com/announcements/456739 (https://www.nzx.com/announcements/456739)
Quote from: LoungeLizard on Aug 13, 2025, 06:22 PMANZ still buying up large. Good sign of confidence.
https://www.nzx.com/announcements/456739 (https://www.nzx.com/announcements/456739)
And Masfen bought a big amount to. https://api.nzx.com/public/announcement/456823/attachment/449572/456823-449572.pdf
Be interesting to see what the Senior Management and Board have bought during CR.
PEB SP appears to be starting its inexorable march northward. Maybe will close at 12c or more today?
Quote from: Pierre on Aug 15, 2025, 10:07 AMPEB SP appears to be starting its inexorable march northward. Maybe will close at 12c or more today?
Yes, there seems to be a growing confidence out there with institutions and high rollers that the next Novitas decision is likely to be a favourable one. ;D
Quote from: Pierre on Aug 15, 2025, 10:07 AMPEB SP appears to be starting its inexorable march northward. Maybe will close at 12c or more today?
Yeah Nah.... 12c still a dream.
Crikey, SP still essentially back where it was in 2020!
Holders may have more confidence in today's PEB management, product and research findings than those of 2020, however there are still major concerns with Trump's health care non-administration.
Wake me up when there is concrete good news.
Quote from: Left Field on Aug 15, 2025, 06:13 PMYeah Nah.... 12c still a dream.
Crikey, SP still essentially back where it was in 2020!
Holders may have more confidence in today's PEB management, product and research findings than those of 2020, however there are still major concerns with Trump's health care non-administration.
Wake me up when there is concrete good news.
No dreaming required.
A day late but the SP hit 12c this afternoon.
More to come over the coming weeks I'm sure as more investors realise success with the LCD is highly likely and decide to jump on board before the inevitable surge in the SP.
Quote from: Pierre on Aug 18, 2025, 03:49 PMNo dreaming required.
A day late but the SP hit 12c this afternoon.
More to come over the coming weeks I'm sure as investors realise success with the LCD is highly likely and decide to jump on board before the inevitable surge in the SP.
My apologies for my last grumpy post Pierre.
I clearly need another dose of your patience.
Supporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*
How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?
*Disc: Includes me.
Quote from: Pierre on Aug 18, 2025, 05:11 PMSupporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*
How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?
*Disc: Includes me.
Likewise. Increased my holding by 10% and if it wasn't for being overweight already I might have bought more. Institutions/ Executives are piling in - a good sign that the smart money knows there's some good news coming.
How high will the SP go when the positive Novitas news hits the boards? Jeez, that a tough one. You've got to think that the SP will hit 50c very quickly - a matter of days or a week at most. But should the decision go their way, PEB will be in a better position than they were when they were at their peak all those years ago. I think the SP got to about $1.56 from memory and since then they have passed further extensive trials and been adopted by the AUA. Plus the re-imbursement level is about a third higher, so becoming cash flow positive would be on the cards.
I don't see any reason why PEB shouldn't eventually get back to that sort of level - $1.50-$2.00 - within 12-18 months of the favorable Novitas decision. It's complete guesswork of course, and nothing has been plain sailing with PEB. It's still high risk stock but I genuinely feel that the odds of a BIG payday are now in PEB's favour.
Quote from: Pierre on Aug 18, 2025, 05:11 PMSupporters of the recent CR will be happy that their investment is worth 22% more with todays closing price of 12.2c.*
How high will the SP go when Novitas approval for Medicare reimbursement is finally received? What's your guess?
*Disc: Includes me.
The million dollar question.
PEB certainly in a better position than they ever have been with AUA guidelines inclusion all sorted.
Its just a matter of knocking and signing contracts. The biggest in the short term would be Novitas. If that happens I expect to see $0.50/$0.60 very quickly. We also see some profit taking which could hold the share price back a little.
I thought the ASM was very positive. Directors have taken shares instead of cash for extra cash payments for their time.
Anatole Masfen quoted that he has never seen PEB in a better decision. He is not a dumb investor.
CEO looked bullish without saying the obvious.
PEB's time for commercial success has started, just a matter of joining the dots.
Huge buy side, and very few sellers. 13c today?
Quote from: LoungeLizard on Aug 19, 2025, 10:04 AMHuge buy side, and very few sellers. 13c today?
And just like that, $0.13 taken out.
Very interesting post from the other site:
AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
Coverage & Payment
Diagnostics
Digital Health
Government & Legislative Affairs
Health Access
Regulatory Affairs
August 20, 2025
WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted medtech enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough medtech faces years of delays in Medicare coverage.
"Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology," the letter states. "A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life."
A streamlined, predictable Medicare coverage pathway for medtech the FDA has deemed useful, safe, and effective would "demonstrate CMS' commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country," the letter continues.
"FDA is the global gold standard with its rigorous medtech safety and efficacy standards," said Scott Whitaker, AdvaMed president and CEO. "When FDA has identified a medtech solution as a 'breakthrough' and cleared it as safe and effective for patients, we believe Medicare should cover it. As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr. Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries' access to the breakthrough medtech that could improve their health and even save their lives."
The letter, including the list of signatories, is available here.
The effort to achieve breakthrough coverage is gaining momentum. In a recent interview, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a "repeat, duplicative approval process."
U.S. senators have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage."
Quote from: LoungeLizard on Aug 24, 2025, 11:35 AMVery interesting post from the other site:
AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
Coverage & Payment
Diagnostics
Digital Health
Government & Legislative Affairs
Health Access
Regulatory Affairs
August 20, 2025
WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted medtech enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough medtech faces years of delays in Medicare coverage.
"Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology," the letter states. "A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life."
A streamlined, predictable Medicare coverage pathway for medtech the FDA has deemed useful, safe, and effective would "demonstrate CMS' commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country," the letter continues.
"FDA is the global gold standard with its rigorous medtech safety and efficacy standards," said Scott Whitaker, AdvaMed president and CEO. "When FDA has identified a medtech solution as a 'breakthrough' and cleared it as safe and effective for patients, we believe Medicare should cover it. As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr. Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries' access to the breakthrough medtech that could improve their health and even save their lives."
The letter, including the list of signatories, is available here.
The effort to achieve breakthrough coverage is gaining momentum. In a recent interview, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a "repeat, duplicative approval process."
U.S. senators have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage."
Well that will be a big dot that will alomost certainly add alot of value to share price.
I wonder what market makes of news like this? Cerainly was an interesting week of trading last week thats for sure.
Quote from: Greekwatchdog on Aug 24, 2025, 12:21 PMWell that will be a big dot that will alomost certainly add alot of value to share price.
I wonder what market makes of news like this? Cerainly was an interesting week of trading last week thats for sure.
This does seem like quite a significant intervention and condemnation of Medicare. It really highlights how the FDA and the US Senate now regard Medicare as being an actual impediment to granting patients access to clinically approved Medtech.
In view of this, together with the sheer weight of clinical evidence and AUA endorsement, it really seems virtually impossible, in my view, for Medicare to contrive a way of turning down re-coverage of CXBladder.
Hard to say how the market will respond. PEB does seem to be on the market radar now with heavy trading most
days last week. I'm starting to think that the Novitas decision might come a lot sooner than expected this time around ;D
Quote from: LoungeLizard on Aug 24, 2025, 01:12 PMThis does seem like quite a significant intervention and condemnation of Medicare. It really highlights how the FDA and the US Senate now regard Medicare as being an actual impediment to granting patients access to clinically approved Medtech.
In view of this, together with the sheer weight of clinical evidence and AUA endorsement, it really seems virtually impossible, in my view, for Medicare to contrive a way of turning down re-coverage of CXBladder.
Hard to say how the market will respond. PEB does seem to be on the market radar now with heavy trading most
days last week. I'm starting to think that the Novitas decision might come a lot sooner than expected this time around ;D
And then you can assume that there will be no issues around all Urologists using the approved products as per guidelines.
Speeding ticket
https://www.nzx.com/announcements/457457
Quote from: Greekwatchdog on Aug 26, 2025, 09:14 AMSpeeding ticket
https://www.nzx.com/announcements/457457
Nothing to see here, is the response. All down to the reported positive meetings with Novitas, and the sense of inevitability in getting Medicare re-coverage.
More good news
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes today that the recommended final 'Gapfill' price for Cxbladder Triage Plus has been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price – a higher price than the US$1,018 draft price proposed in April this year.
The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance for Triage Plus subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration request for Triage Plus shortly after the publication of the DRIVE Study that is currently in peer review.
Hematuria evaluation tests currently represent around 83% of Pacific Edge's total US laboratory throughput . The US$1,328.32 price is a meaningful increase compared to the US$760 CMS price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that MolDX has recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32 and that CMS has recommended this as a final price. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk."
The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics are used in our existing budget impact model we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most."
The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is typically not expected to change, and is expected to become effective from 1 January 2026.
Quote from: Greekwatchdog on Sep 10, 2025, 10:18 AMMore good news
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes today that the recommended final 'Gapfill' price for Cxbladder Triage Plus has been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price – a higher price than the US$1,018 draft price proposed in April this year.
The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance for Triage Plus subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration request for Triage Plus shortly after the publication of the DRIVE Study that is currently in peer review.
Hematuria evaluation tests currently represent around 83% of Pacific Edge's total US laboratory throughput . The US$1,328.32 price is a meaningful increase compared to the US$760 CMS price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline.
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are very pleased that MolDX has recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32 and that CMS has recommended this as a final price. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk."
The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics are used in our existing budget impact model we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most."
The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is typically not expected to change, and is expected to become effective from 1 January 2026.
Nice little boost for the SP ahead of the main event - coverage being re-instated. The "gap fill" price of $1328 is nearly double the old amount representing a massive boost in revenue and margins.
And note that PEB dropped this into the announcement "When coverage of Triage Plus is established..." i.e such is their confidence they are not even saying "if" anymore.
ASX trading is interesting..
Last Price / Today's Change
$0.185 +$0.054 (42.307%)
Volume
281,946
Bid / Offer Range
$0.140 - $0.185
Quote from: Greekwatchdog on Sep 10, 2025, 12:28 PMASX trading is interesting..
Last Price / Today's Change
$0.185 +$0.054 (42.307%)
Volume
281,946
Bid / Offer Range
$0.140 - $0.185
Interesting thanks for posting.....some say today's SP rise is a tab too optimistic.
Some also say, it's not optimistic enough..... If today's news means a doubling of current revenue in 2026 (even without Novitas) then PEB's SP should be around $NZ0.20c.....?
Anyway whatever they say, it's been a nice day for holders.
Novitas Proposes Expert Panel in Response to 2025 AUA Guide
15/09/2025, 09:03 NZST, GENERAL
Novitas Proposes Expert Panel in Response to 2025 AUA Guideline
DUNEDIN, New Zealand – Pacific Edge (NZX, ASX: PEB) today announces it has received notification from Medicare Administrative Contractor (MAC) Novitas that it intends to convene an expert panel to consider coverage for tests mentioned in the 2025 update to the American Urological Association (AUA) microhematuria guideline, including Cxbladder Triage.
The panel — known as a Contractor Advisory Committee (CAC) — is likely to be convened in early 2026. It will be comprised of urology subject matter experts and will be tasked with considering how to bring Medicare policy into alignment with the 2025 update to the AUA guideline.Pacific Edge notes that under the Medicare Program Integrity Manual, CAC meetings are initiated by the MAC and generally precede the draft issuance of a new or substantially revised Local Coverage Determination (LCD).
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are pleased that Novitas has acknowledged the importance of the AUA microhematuria guideline and is taking a robust and credible approach to policy development by convening a panel of urologists who understand the latest update to the guideline. It is also recognition of the important role that randomized controlled trials like our STRATA1 study and guidelines play in the development of medical policy like LCDs."
Quote from: Greekwatchdog on Sep 15, 2025, 09:09 AMNovitas Proposes Expert Panel in Response to 2025 AUA Guide
15/09/2025, 09:03 NZST, GENERAL
Novitas Proposes Expert Panel in Response to 2025 AUA Guideline
DUNEDIN, New Zealand – Pacific Edge (NZX, ASX: PEB) today announces it has received notification from Medicare Administrative Contractor (MAC) Novitas that it intends to convene an expert panel to consider coverage for tests mentioned in the 2025 update to the American Urological Association (AUA) microhematuria guideline, including Cxbladder Triage.
The panel — known as a Contractor Advisory Committee (CAC) — is likely to be convened in early 2026. It will be comprised of urology subject matter experts and will be tasked with considering how to bring Medicare policy into alignment with the 2025 update to the AUA guideline.Pacific Edge notes that under the Medicare Program Integrity Manual, CAC meetings are initiated by the MAC and generally precede the draft issuance of a new or substantially revised Local Coverage Determination (LCD).
Pacific Edge Chief Executive Dr Peter Meintjes said: "We are pleased that Novitas has acknowledged the importance of the AUA microhematuria guideline and is taking a robust and credible approach to policy development by convening a panel of urologists who understand the latest update to the guideline. It is also recognition of the important role that randomized controlled trials like our STRATA1 study and guidelines play in the development of medical policy like LCDs."
The stars are aligning. Sounds very much like Novitas finally recognise that non-coverage is out of step with medical evidence and the governing urological body. Can't see how bringing things into "alignment" could mean anything less than granting coverage. Great news for holders!
SP nearly doubled since the SPP... Great month for holders and those who believed enough to throw down some more $$$.
Quote from: raW tent Buffer on Sep 15, 2025, 10:36 AMSP nearly doubled since the SPP... Great month for holders and those who believed enough to throw down some more $$$.
Yep, great times for those that kept the faith. Having said that, those arriving late at the party could still reap a substantial reward when coverage is finally re-instated.
Those who have kept the faith have found the tithe rather costly.
Disc .Luckily never had the PEB faith.
Quote from: lorraina on Sep 15, 2025, 04:14 PMThose who have kept the faith have found the tithe rather costly.
Disc .Luckily never had the PEB faith.
How do you figure that? Those (like me), that participated in the 10c cap raise only 6 weeks ago have doubled their money. Those (like me) that kept the faith before that and averaged down have done even better.
It's been a long, bumpy ride for sure, but it's also been good to support a terrific, well run NZ company that has developed an internationally recognised, cutting-edge diagnostic tool that literally saves lives. PEB deserve the success that is (hopefully) coming their way. Likewise, long-suffering investors!
A friend of mine loved the story a good few years ago and she bought in at around 80 cents.
[And from memory paid even more in one of their numerous capital raises.]
Did this friend bail out when the shares were $1.60? Lots of options at play since then.
Ultimately its called investing, everyone has a story to tell.
Funny thing, PEB is just started another chapter..
Third time trying to reply.???
No she kept the faith.
Starting another chapter.?
Not so.Book 2 in the PEB trilogy series of novels.
Quote from: lorraina on Sep 15, 2025, 05:38 PMThird time trying to reply.???
No she kept the faith.
Starting another chapter.?
Not so.Book 2 in the PEB trilogy series of novels.
You had a Gin or maybe 3 before tea then?
Good on her.
Yes.
PEB more like the bible. You read Sword of Shannara series? I think its up to 27 novels.....
No like PEB I would avoid them...
Just as well we spend our own money the way we like then whether it be investing or purchasing books.
Seems to me lorraina you are showing yourself up as being illinformrd. If you have followed this company closely and the news flow of the past 3 years I think you would have a different sentiment at this time. I admit that the situation PEB finds itself in is disappointing and they are an easy target given the length of time taken and the patience required by shareholders. However given the amount of real world evidence from various jurisdictions, and now most importantly the AUA 'A'grade approval, there is no question that their products work and are poised to make a step change in the standard of care for patients presenting with hematuria. They are now in the strongest position in their long history to convert the opportunity for shareholders. The US market is significant and the rest of the world awaits! Why don't you do some homework! It's not too late!!
Quote from: Highgate on Sep 15, 2025, 07:33 PMSeems to me lorraina you are showing yourself up as being ill-informed. If you have followed this company closely and the news flow of the past 3 years I think you would have a different sentiment at this time.
I admit that the situation PEB finds itself in is disappointing and they are an easy target given the length of time taken and the patience required by shareholders. However given the amount of real world evidence from various jurisdictions, and now most importantly the AUA 'A'grade approval, there is no question that their products work and are poised to make a step change in the standard of care for patients presenting with hematuria.
They are now in the strongest position in their long history to convert the opportunity for shareholders. The US market is significant and the rest of the world awaits! Why don't you do some homework! It's not too late!!
Indeed.
Lorraina/Percy's comments just show different strokes for different folks.
Lorraina/Percy more aligned to dividend and retail stocks I suspect.
Other investors are aligned more to little Kiwi companies that can take on the world outside NZ....some also welcome the prospects of significant tax free capital gains.... some examples.
XRO was deemed a risky stock for a many years and the SP has shown some huge historical fluctuations on the path to success. When I first purchased XRO it was a $40 share, then the SP fell as low as $15. I did my research and backed XRO buying more at lower SPs until my av holding SP was in the low $20s...... fast forward to XRO today....... you get the idea.
I've now followed pretty much the same route with; ATM, GTK, IFT, TWR, FPH, IKE etc....(some still in my portfolio and some now gone.)
The trick is to do your research, buy your shares in small increments and continually work at improving your average holding SP by buying more in the 'lows' (but only if you are confident in the products and management's skills.)
Before Novitas my PEB av holding SP cost was $0.40..... this was fine when PEB climbed to around $1.40 and all was rosey...however when Novitas decision crashed the SP, it was a case of not panicking, waiting to see how management handled the issue, then acting... Once I determined that the downside risk was minimal compared to the upside I gradually increased my PEB holding by 500% buying in around the 10c mark...... and I am now reaping the rewards.
I think the current iteration of PEB is the best it has ever been and the prospects ahead are exciting. Even the TA looks promising.
Holders are now well positioned IMO...... however there will always be other investors who differ.
Quote from: Left Field on Sep 16, 2025, 08:02 AMIndeed.
Lorraina/Percy's comments just show different strokes for different folks.
Lorraina/Percy more aligned to dividend and retail stocks I suspect.
Other investors are aligned more to little Kiwi companies that can take on the world outside NZ....some also welcome the prospects of significant tax free capital gains.... some examples.
XRO was deemed a risky stock for a many years and the SP has shown some huge historical fluctuations on the path to success. When I first purchased XRO it was a $40 share, then the SP fell as low as $15. I did my research and backed XRO buying more at lower SPs until my av holding SP was in the low $20s...... fast forward to XRO today....... you get the idea.
I've now followed pretty much the same route with; ATM, GTK, IFT, TWR, FPH, IKE etc....(some still in my portfolio and some now gone.)
The trick is to do your research, buy your shares in small increments and continually work at improving your average holding SP by buying more in the 'lows' (but only if you are confident in the products and management's skills.)
Before Novitas my PEB av holding SP cost was $0.40..... this was fine when PEB climbed to around $1.40 and all was rosey...however when Novitas decision crashed the SP, it was a case of not panicking, waiting to see how management handled the issue, then acting... In time I increased my PEB holding by 500% around the 10c mark and am now reaping the rewards.
I think the current iteration of PEB is the best it has ever been and the prospects ahead are exciting.
Holders are now well positioned IMO...... however there will always be other investors who differ.
Followed the same path, LF - bought early on, kept buying through the crash and capital raises, got my average price down to 16c and now "well-positioned" should coverage be re-instated. I'm holding just shy of 700k shares - more than sensible - but sometimes you have to back your instincts. I did that with ATM not long after they joined NZX and that was a life-changing investment decision. ;D
In the 1990s I bought into some small cap Aussie biotech stocks.
All were expecting FDA approval was just around the corner.
Wrong.All failed and went broke.
Having a poor memory 25 years later I thought I had found a winner and posted this on the other channel.
UCM Uscom Ltd
USCOM Limited is engaged in the development, design, manufacture and marketing of premium non-invasive cardiovascular and pulmonary medical devices. The Company manages a network of distribution partners across the world for the sale of its equipment to hospitals and other medical care locations. Its geographic segments include Australia, Asia, the Americas, Europe and Mid East and Africa, and Other Regions.
150,513,275 shares on issue at 17 cents gives a market cap of $28,112,557.
Strong balance sheet,good cash flow,profitable and holding a good amount of cash.Growth for the coming year looks as though it will be out standing,being driven by momentum and new products.
Interesting seeing today UCM's market cap is just $2.8 mil.Managed to get out with my capital intact.
On ASX watch list I have 4DX and ARX,but do not have shares in either.
I have stayed away from TRU TruScreen.
Not a sector I will invest in,however medical supply companies such as EBO,and PGC interest me.
Lorriana ....did you ever have Ventracor early this century. They did artificial hearts.
Ramped like a buggery on forums and share price ups and downs were exciting.
No .Missed that one.
I did hold Skyepharma in UK.
Can not remember what happened to them.
From a TA perspective a new 'base' is forming around the 20c level now that the 15 Sept breakaway gap between .16 -.17c has been filled.
Encouraging support bodes well for further upside.
Quote from: Left Field on Oct 01, 2025, 07:32 PMFrom a TA perspective a new 'base' is forming around the 20c level now that the 15 Sept breakaway gap between .16 -.17c has been filled.
Encouraging support bodes well for further upside.
Due for 2nd quarter update within the next week, be interesting if they have increased test numbers out of US since intro into guidelines.
Ultimately we will move on + annoucements.
Quote from: Greekwatchdog on Oct 01, 2025, 07:38 PMDue for 2nd quarter update within the next week, be interesting if they have increased test numbers out of US since intro into guidelines.
Ultimately we will move on + annoucements.
I guess the question is whether test volumes continue to dip because of novitas coverage ending in April, if they increase because AUA guideline awareness increases, or these two factors balance each other out?
Quote from: SuperMario on Oct 02, 2025, 01:44 AMI guess the question is whether test volumes continue to dip because of novitas coverage ending in April, if they increase because AUA guideline awareness increases, or these two factors balance each other out?
I am looking at the US numbers past Novitas (No point in worrying about them until it gets sorted).
New clients/contracts etc. Also how things are working out in other markets off low bases.
Lower USD will also have been helpful during 2nd quarter. Any more clinicial evidence being provided.
All about joining the dots
Quote from: Left Field on Oct 01, 2025, 07:32 PMFrom a TA perspective a new 'base' is forming around the 20c level now that the 15 Sept breakaway gap between .16 -.17c has been filled.
Encouraging support bodes well for further upside.
Dead right, LF - pushing through to 21c today with good buyer support to go further in the days ahead.
Quote from: Greekwatchdog on Oct 02, 2025, 07:00 AMI am looking at the US numbers past Novitas (No point in worrying about them until it gets sorted).
New clients/contracts etc. Also how things are working out in other markets off low bases.
Lower USD will also have been helpful during 2nd quarter. Any more clinicial evidence being provided.
All about joining the dots
Good point!
Update attached.
https://www.nzx.com/announcements/460568
2 points of interest
Novitas, our Medicare AdministrativeContractor has announced its intention toconvene a panel of experts called aContractor Advisory Committee(CAC) to "to discuss evidence forthe use of urine-based biomarkersin patients with microhematuria."The CAC is tentatively scheduledfor February 19, 2026 at 6pm ETand demonstrates that Novitasrecognizes the importance ofthe AUA's update to the 2025Microhematuria Guideline andunderstands the strength of theevidence supporting our tests (seepage 5)
Since the non-coverage determination took effectin April, we have continued to seek reimbursementfor Cxbladder Triage on the grounds that Guidelinerecommended tests are medically reasonable andnecessary and therefore eligible for reimbursementunder the US Social Security Act.While initial claims for Triage tests have beendenied as expected, we have filed appeals for asubstantial portion of these claims and expect tohave them heard by an Administrative Law Judge(ALJ). Given the strength of the new evidence from2024 (STRATA) and 2025 (AUA MicrohematuriaGuideline) that was not considered during theestablishment of the LCD, Pacific Edge sees a highprobability of success on appeal.
However, statutory timeframes of the appealsprocess are protracted, and we do not expect theseefforts to begin contributing to revenue until thesecond half of this financial year
The quarterly numbers aren't great but largely expected.
Useful information surrounding the CAC meeting and on-going legal appeals. I certainly get the sense of frustration from the CEO, but still a case of being patient. PEB explicitly state that it is a question of when rather than if inclusion is reinstated. Might top up further if there's a dip in the SP.
Quote from: LoungeLizard on Oct 14, 2025, 10:02 AMThe quarterly numbers aren't great but largely expected.
Useful information surrounding the CAC meeting and on-going legal appeals. I certainly get the sense of frustration from the CEO, but still a case of being patient. PEB explicitly state that it is a question of when rather than if inclusion is reinstated. Might top up further if there's a dip in the SP.
A few nervous Nellie's bailing, or profit-taking on this morning's not unexpected news. This presents a good buying opportunity for anyone wanting to top up their holding in anticipation of a positive outcome from Novitas in 2026.
We will likely see a bit of a bounce-back in the SP this afternoon.
I increased my share total by 25% in the recent CR so I'm holding steady right now.
Quote from: Pierre on Oct 14, 2025, 10:38 AMA few nervous Nellie's bailing, or profit-taking on this morning's not unexpected news. This presents a good buying opportunity for anyone wanting to top up their holding in anticipation of a positive outcome from Novitas in 2026.
We will likely see a bit of a bounce-back in the SP this afternoon.
I increased my share total by 25% in the recent CR so I'm holding steady right now.
Dead right there, Pierre. A few bailing this morning but SP is now up for the day.
I actually thought that the SP would get a lift on some of the encouraging detail in the quarterly report especially the part that said PEB "sees a high probability of success" in their appeal case for "a substantial portion" of retrospective claims to be re-imbursed on the grounds that that they were erroneously denied.
Good strategy to keep lodging claims I thought.
Quote from: LoungeLizard on Oct 14, 2025, 04:15 PMDead right there, Pierre. A few bailing this morning but SP is now up for the day.
I actually thought that the SP would get a lift on some of the encouraging detail in the quarterly report especially the part that said PEB "sees a high probability of success" in their appeal case for "a substantial portion" of retrospective claims to be re-imbursed on the grounds that that they were erroneously denied.
Good strategy to keep lodging claims I thought.
Yes, the report was positive, but still speculative, so I guess we cant blame investors for remaining cautious until the probability turns into reality. Once that happens though, it's game on and there will be many regretting their caution at this time.
Posted om the other channel by Psychic
Veterans Drive Study published
https://scholar.google.co.nz/scholar...&pos=0&folt=kw
Extract from last PE update:
This publication provides the clinical validation evidence necessary for us to formally request our Medicare Administrative Contractor Novitas to consider coverage for Triage Plus
Thanks GWD
This link may work better for some....
https://www.sciencedirect.com/science/article/pii/S1078143925004053
Onwards and upwards
The evidence has been overwhelmingly in favour of CXBladder for some time, and this is yet another validation. For whatever reason Novitas have done their utmost to ignore the evidence and expert opinion, but the game is up now. Shame we still have to wait until January for the meeting and then for whatever time they think they need to deliberate. Really, what is left to debate?
Quote from: LoungeLizard on Nov 04, 2025, 01:26 PMThe evidence has been overwhelmingly in favour of CXBladder for some time, and this is yet another validation. For whatever reason Novitas have done their utmost to ignore the evidence and expert opinion, but the game is up now. Shame we still have to wait until January for the meeting and then for whatever time they think they need to deliberate. Really, what is left to debate?
Cost... It's all about the bottom line. The test is too easy. A simple bio marker won't be as cost effective for Novitas as the current system is prohibitive.
Quote from: Mad Goat Keeper on Nov 05, 2025, 04:02 PMCost... It's all about the bottom line. The test is too easy. A simple bio marker won't be as cost effective for Novitas as the current system is prohibitive.
I don't get that - if it's easier then isn't it by default going to be cheaper?
Kaiser Permanente , the biggest non-profit health provider in the US - has been using CX Bladder for sometime, so there's a lot of data from them on the benefits of using CXBLadder. They estimate that they have cut the number of unnecessary cystoscopies by two thirds which apparently translates to a saving of US$560 per patient.
I think the delay in adoption is probably more to do with Medicare being notoriously slow to introduce new tests and even new drugs approved by the FDA. They've been criticised for this by a wide range of patient advocacy groups as well as the DOH itself.
Quote from: Mad Goat Keeper on Nov 05, 2025, 04:02 PMCost... It's all about the bottom line. The test is too easy. A simple bio marker won't be as cost effective for Novitas as the current system is prohibitive.
Your comment makes no sense at all.
The PEB bio marker test
WILL be cost-effective compared with cystoscopy.
Quote from: Pierre on Nov 05, 2025, 05:02 PMYour comment makes no sense at all.
The PEB bio marker test WILL be cost-effective compared with cystoscopy.
The test is much cheaper than a cystocopy, better for the patient and enviroment.
What PEB are dealing with is Amercian dumb arse. Remember 52% + voted for the most repulsive president on record.
Quote from: LoungeLizard on Nov 05, 2025, 04:21 PMI don't get that - if it's easier then isn't it by default going to be cheaper?
Kaiser Permanente , the biggest non-profit health provider in the US - has been using CX Bladder for sometime, so there's a lot of data from them on the benefits of using CXBLadder. They estimate that they have cut the number of unnecessary cystoscopies by two thirds which apparently translates to a saving of US$560 per patient.
I think the delay in adoption is probably more to do with Medicare being notoriously slow to introduce new tests and even new drugs approved by the FDA. They've been criticised for this by a wide range of patient advocacy groups as well as the DOH itself.
Patients avoiding unnecessary cystoscopies is the ideal scenario so a saving would be expected. Those not so lucky would still require cystoscopies and the expensive bit, treatment...
It may well prove financially beneficial over time but you can guarantee this is numbers game and not an outcomes game.
PEB playing soothing music while it places investors on hold......
Latest update....a test of investor patience.
https://api.nzx.com/public/announcement/463313/attachment/457570/463313-457570.pdf
Quote from: Left Field on Nov 25, 2025, 12:02 PMPEB playing soothing music while it places investors on hold......
Latest update....a test of investor patience.
https://api.nzx.com/public/announcement/463313/attachment/457570/463313-457570.pdf
As an investor I had no expectations on this result. Short term its all about news until issue with Novitas is resolved.
Listened to the meeting, CEO very confident on gaining coverage.
Possibly may need more cash in 9/12 months, who knows.
The Medicare decision is a make or break moment for PEB and investors. Should there be a favourable decision (highly likely) all numbers will instantly look good, particularly with the reimbursement rate being 75% higher and with the backlog of cases, currently not being funded, forming a large instant revenue boost.
I thought they would have enough funds to see them through the whole Novitas process, but maybe not.
These updates on where the business is now, without Medicare coverage, are largely irrelevent - it's all about a future where re-imbursement resumes. That future looks very, very good. It just needs to hurry up and arrive!
Quote from: LoungeLizard on Nov 25, 2025, 12:57 PMThe Medicare decision is a make or break moment for PEB and investors. Should there be a favourable decision (highly likely) all numbers will instantly look good, particularly with the reimbursement rate being 75% higher and with the backlog of cases, currently not being funded, forming a large instant revenue boost.
I thought they would have enough funds to see them through the whole Novitas process, but maybe not.
These updates on where the business is now, without Medicare coverage, are largely irrelevent - it's all about a future where re-imbursement resumes. That future looks very, very good. It just needs to hurry up and arrive!
Peter Meintjes is supremely confident of a positive outcome from Novitas. The question is when will the decision arrive - and Q3 or Q426 seems to be highly likely, but not guaranteed. Worst case is Q327.
Having sufficient cash until the result is known is the second issue. They were very cagey about that and how it would be dealt with, but indicated they may have some trick up their sleeve that would avoid them calling on shareholders for support.
I feel certain there will definitely be gold at the end of the rainbow. Patience grasshopper.
Yes well said Pierre and LL..... my post earlier today was rather tongue in cheek....I'm used to being patient with PEB.
FWIW there was a really good interview this morning with Kathryn Ryan and RNZ's financial reporter who had spent some time reviewing ACC's investments and talking to one of their investment managers.
The upshot was that ACC likes having shareholdings in NZX small caps ( often too small to warrant the attention of brokers etc) as although they are risky....it is where ACC makes its most impressive gains, (or words to that effect.)
Craigs latest say sell 9cps TP
Rob Morrison's Title for Pacific Edge "No longer flush with cash" clearly signals the looming issue for the company after yesterday's interim result. Morrison's extensive channel checks and clinical study deep dives indicate that Cxbladder delivers good clinical/economic value and should regain Medicare coverage by FY28 a view that is unchanged since 2023 and consistent with PEB's updated timeline released yesterday. However, in the interim, more cash is needed with PEB's cash balance at $22m (30 September) and a burn-rate of c$20m every 6 months on recent run-rates. Morrisons Target Price is unchanged at 9cps and with the shares now trading at 17cps his recommendation moves from Neutral to Underweight.
Quote from: Shareguy on Nov 26, 2025, 12:18 PMCraigs latest say sell 9cps TP
Rob Morrison's Title for Pacific Edge "No longer flush with cash" clearly signals the looming issue for the company after yesterday's interim result. Morrison's extensive channel checks and clinical study deep dives indicate that Cxbladder delivers good clinical/economic value and should regain Medicare coverage by FY28 a view that is unchanged since 2023 and consistent with PEB's updated timeline released yesterday. However, in the interim, more cash is needed with PEB's cash balance at $22m (30 September) and a burn-rate of c$20m every 6 months on recent run-rates. Morrisons Target Price is unchanged at 9cps and with the shares now trading at 17cps his recommendation moves from Neutral to Underweight.
Strange logic from Craigs, given that they accept that PEB "should regain" coverage yet have a target price of half the current price. Seems very short-sighted to value the company independent of regaining coverage, given how overwhelmingly positive the SP will respond when that happens.
This very patient holder is pleased to see a worthy appointment to replace David Levison in a crucial role for PEB.
https://www.nzx.com/announcements/463478
New Chair announced......
https://www.nzx.com/announcements/463929
Interest in PEB seems to have picked up a little recently and the SP has crept up to 18.1cps at opening today.
Maybe some punters are positioning themselves for positive news at the Novitas CAC meeting on 19 February?
While a Medicare coverage decision won't be announced immediately, the tone of the meeting should give a pretty good clue as to the likely eventual outcome.
Latest update from PEB.
https://api.nzx.com/public/announcement/466143/attachment/460697/466143-460697.pdf
Lab tests continue to struggle...... much resting on the 20th Feb LCD/CAC meeting. Also interesting to hear progress on PEB's ongoing legal case to pursue compensation for all Cxbladder Triage tests denied reimbursement.
"This ALJ hearing is a determinative stage of the Medicare appeals pathway we are pursuing for all eligible Cxbladder Triage tests that have been denied Medicare reimbursement since the Cxbladder non-coverage determination took effect in April 2025...... Consistent success in overturning denials could materially influence FY26 and FY27 revenue, by establishing a precedent for the more than 1,650 tests that have been denied reimbursement to date."
Very positive update regarding the engagement with Novitas prior to the meeting in February. One gets the sense that all the ducks have been lined up and the LCD decision should be a formality. Timely news also that another provider ( Avalon Healthcare Systems) has endorsed Cxbladder Triage.
PEB - stock on the ASX briefs podcast this week.
For those interested, Link to ASX interview
https://ausbiz.com.au/media/the-small-cap-awaiting-its-medicare-moment?videoId=46361§ionId=1885
Sent to investors today:
Kaiser Study Backs Triage Ahead of Medicare Panel
Dear Investor,
Pacific Edge welcomes the publication in the journal Urology Practice of a Kaiser Permanente study demonstrating the real-world Clinical Utility of Cxbladder Triage in the largest ever urine-based biomarker study on patients presenting with hematuria1.
The publication, which used a 3,353-patient risk-matched cohort (n=6,706) to determine the real-world reduction in cystoscopies and imaging (CT scans), concluded that Cxbladder Triage avoided 952 cystoscopies and 70 CT scans reinforcing the previously published findings of 59% relative reduction in cystoscopies from the prospectively enrolled, randomized controlled STRATA Study2.
This publication comes at an important time for Pacific Edge, because peer-reviewed publications can be considered by the Contractor Advisory Committee (CAC) that Novitas, our Medicare Administrative Contractor, will use to develop coverage language when it publishes a draft local coverage determination (LCD) that governs Medicare reimbursement for Cxbladder tests. The CAC has been tentatively scheduled by Novitas for 6pm on 19 February 2026 (US ET).
Pacific Edge Chief Executive, Dr Peter Meintjes, said: "Real-world evidence from one of the largest integrated healthcare systems in the US is significant, but in this case particularly so, because the study has a sample size of 3,353 risk-match patients, unequivocally demonstrating reduction in cystoscopy at scale.
"The study reinforces the existing clinical evidence that Cxbladder Triage can safely reduce unnecessary invasive procedures for low and intermediate risk patients and help clinicians focus cystoscopies and imaging on those at higher risk."
The retrospective study considered patients evaluated according to the new clinical pathway that includes Cxbladder Triage against a risk-matched cohort of patients from the same time period that did not receive Cxbladder Triage. The primary endpoints of the study were to compare the number of cystoscopies and imaging procedures (CT scans) between the new standard of care incorporating Cxbladder Triage and the prior standard of care, while monitoring cancer detection rates. Its key findings were:
The cystoscopy rate of patients classified by Cxbladder Triage as having a 'Low Probability' of urothelial cancer, was just 3.8%, compared with 46.5% in the risk-matched group.
The cystoscopy rate in patients with 'High Probability' Triage scores was 73.4%, versus 45.7% in the standard-of-care group, indicating more appropriate use of invasive procedures in those most at risk.
Overall bladder cancer detection rates between the Cxbladder Triage patients and the standard-of-care patients were similar (0.6% vs 0.7%), confirming that unnecessary procedures were reduced without compromising cancer detection.
The authors concluded: "Cxbladder Triage testing significantly decreased cystoscopy and imaging utilization among low-risk microscopic hematuria patients while simultaneously increased use among higher-risk patients. Cancer detection was consistent among patients in both groups."
Dr Meintjes said such a retrospective study and the evidence generation are uniquely available in the Kaiser Permanente system. It underscored the value of Pacific Edge's partnership with the healthcare provider and the shared commitment of both organizations to improving patient outcomes.
"The study publication provides powerful, independent confirmation of Cxbladder's value in everyday clinical practice. That is a compelling message for payers, providers, those attending the CAC in February and, most importantly, for patients who may otherwise face an invasive procedure they do not need," Dr Meintjes said.
Just more great news, be interesting to see how the share price treks heading into 20th Feb meeting with Novitas.
Trading at 20 cents each
Quote from: Habitz on Jan 27, 2026, 12:38 PMTrading at 20 cents each
Not today, closer to the 20th as we head to a Non Trading period whilst the meeting goes on.
With just over three weeks to the meeting, where a favourable outcome is almost certain, you would have to think that there should be a bit of lift in the SP leading up to 20 Feb, as new investors/traders move in for a quick doubling (at least) of their stake.
This study and results is truly impressive......and nice to see the market reaction today.
However I'm not expecting an answer to all PEB's prayers immediately after the 20th Feb meeting.
Just saying, things may take longer (as we've seen before with PEB) and best to remain wary of the USA medicare systems under the current admin.
So 'well positioned', and 'cautious optimism' are my thoughts at the moment.
Just wondering out loud. When do the remainder of the KP buisness empire switch the lights on and adopt CX Bladder Triage +?
You would think after this there must be a number of wheels turning..
As a patient holder, the news release and price action are welcome.
But I'm also tipping a clip around the ear from the market overseers, since a 15%+ intraday rise today suggests that this should've been a market news release rather than shareholder email and (presumably) press release, and furthermore should've been marked as price-sensitive.
Quote from: bulltrap on Jan 27, 2026, 03:19 PMAs a patient holder, the news release and price action are welcome.
But I'm also tipping a clip around the ear from the market overseers, since a 15%+ intraday rise today suggests that this should've been a market news release rather than shareholder email and (presumably) press release, and furthermore should've been marked as price-sensitive.
Yeah, maybe. To be honest other reports with this sort of data haven't received this sort of price reaction. I think its more to do with that the commentary on last weeks update was very positive.
This just supports and we could be seeing alot of investors position themselves ahead of the 20th with a number not prepared to sell.
Quote from: Greekwatchdog on Jan 27, 2026, 03:26 PMYeah, maybe. To be honest other reports with this sort of data haven't received this sort of price reaction. I think its more to do with that the commentary on last weeks update was very positive.
This just supports and we could be seeing alot of investors position themselves ahead of the 20th with a number not prepared to sell.
Could be too, and to be fair, I think they used to do more market announcements at this level and may've got told off for spamming.
It's hard to get the balance right, but you could argue that if it's worth saying anything in the public domain, the market should be CC'ed in. And seeing the detail what comes out every time a junior miner picks its nose, the bar is set very high for TMI.
Quote from: bulltrap on Jan 27, 2026, 03:41 PMCould be too, and to be fair, I think they used to do more market announcements at this level and may've got told off for spamming.
It's hard to get the balance right, but you could argue that if it's worth saying anything in the public domain, the market should be CC'ed in. And seeing the detail what comes out every time a junior miner picks its nose, the bar is set very high for TMI.
I agree. I personally think these sort of annoucements should be put on NZX for all investors whether thay are a holder or have on their watch list.
That way they cover there back side and don't get told off.
Pick a number for close of trade... my pick 22 cents each
I think $0.25 but also understand that there are those investors out there who will sell some if not all their holding during trading heading towards 20th Feb. ie similar trading like yesterday.
After all who wouldn't trim/sell if you bought in or average around $0.10??
I am holding
Quite right. For a share which was valued over $1 it's been a painful experience for many, but good for those who bought at approx 5 to 10 cents. No justice yet, the risk is still there.
https://www.nzx.com/announcements/467094
As PEB said, although the final decision won't be made at the meeting, "The opinions expressed during the meeting...are expected to have an influence over the language Novitas uses in any draft Local Coverage Determination (LCD).
In other words, investors will probably know which way the wind is blowing on 20th. Not long now!
Quote from: LoungeLizard on Feb 09, 2026, 10:57 AMhttps://www.nzx.com/announcements/467094
As PEB said, although the final decision won't be made at the meeting, "The opinions expressed during the meeting...are expected to have an influence over the language Novitas uses in any draft Local Coverage Determination (LCD).
In other words, investors will probably know which way the wind is blowing on 20th. Not long now!
I'm pretty sure we know which way the wind is blowing. Hopefully, on the 20th, we will find out if it's a gentle breeze or a force 10 gale.
I consulted the Chatgpt guru about prospects for a good outcome. Came back with:
Positive LCD – Full Coverage for Triage (and maybe Triage Plus) up to 50 percent chance and 0.75 – $1.10 shareprice
Partial Coverage / Restrictive LCD up to 30 percent, company still viable, shareprice 0.35 – $0.60
And the option none of us want 0.10 – $0.20 shareprice, that's by far the least risk and only a small loss of value if correct.
Need I say but this is purely speculation and shouldn't be relied upon
Seems like the market likes those odds. SP up 7.5% to 22c this morning.
Debate on the other channel about the prospects of a cap raise or whether they have tapped up a major investor (ANZ?) to get them through to when a new LCD comes in force. Some conjecture as well as to whether they are looking at getting a US partner onboard or even listing on the Nasdaq.
All speculation of course, but that's half the fun. ;D
If the meeting goes well and there's strong indication that there will be a favourable decision, then maybe that will be the time to do a capital raise ie when the SP is elevated and there's a buzz about the company?
Lol. Just bought in this morning. Have been thinking about it for last couple months. Now it is FOMO. Last time I bought in at 83c and sold them the next day for 81c about 4 years ago. Luckily only lost $380. It is all a bit of fun with play money.
Quote from: seaweed on Feb 10, 2026, 12:15 PMLol. Just bought in this morning. Have been thinking about it for last couple months. Now it is FOMO. Last time I bought in at 83c and sold them the next day for 81c about 4 years ago. Luckily only lost $380. It is all a bit of fun with play money.
Yeah, that's the way to view it, Seaweed - throw some spare cash at it and roll the dice. A few of us have gone deeper than is wise, but it looks as though PEB might - might - be one of those stocks that favours the brave.
All looking good though - now up nearly 15% on the day. And this is just on the back of speculation that a favourable decision is just around the corner. Goodness knows what the SP will do if/when that decision is made. SP will double pretty much straight away is my view. :P
Big day on Friday for PEB and holders with the Novitas Contractor Advisory Committee meeting scheduled to kick off in the US at noon NZT.
The shares will go into a trading halt before the meeting starts until 10am Monday, so Friday morning is the last opportunity to take a punt on everything sounding positive at the meeting and the gold rush potentially starting on Monday.
The actual decision on Medicare coverage will be some months away but the tone of submissions at the meeting is sure to provide a pretty good indication of the likely outcome.
Fingers crossed.
Agree that the tone of the meeting and the questions and opinions expressed will probably provide a strong indicator of what the eventual decision will be. PEB have said as much and hence the trading halt.
All the best to fellow long suffering shareholders.
Here's the link to register for the Novitas webinar:
https://fcso.webex.com/weblink/register/red3f833b75a2f3922d04ada5d71a6aee
Here it is, trading halt. Info attached
https://api.nzx.com/public/announcement/467848/attachment/462723/467848-462723.pdf
Quote from: Greekwatchdog on Feb 20, 2026, 08:35 AMHere it is, trading halt. Info attached
https://api.nzx.com/public/announcement/467848/attachment/462723/467848-462723.pdf
Effective from start of trading today so no chance for last minute buying before the CAC meeting.
Now we wait for the meeting and the release of PEB's report on the content. Monday's trading will be interesting!
Those who want to listen in to this Medicare CAC meeting. It starts midday today NZT and is estimated to run for two hours and is accessible to the public by registering at the link below.
https://fcso.webex.com/weblink/register/red3f833b75a2f3922d04ada5d71a6aee (https://fcso.webex.com/weblink/register/red3f833b75a2f3922d04ada5d71a6aee)
I registered just now and got an immediate approval through. Good luck to all faithful holders
No chance for last minute selling if have cold feet
I'm into Webex on my phone and am now on standby waiting for the meeting to start.
It seemed a bit of a drama getting connected (maybe my fault) but I recommend accessing the system early so you dont miss any of the action.
Quote from: Pierre on Feb 20, 2026, 11:36 AMI'm into Webex on my phone and am now on standby waiting for the meeting to start.
It seemed a bit of a drama getting connected (maybe my fault) but I recommend accessing the system early so you dont miss any of the action.
Worked fine from my laptop. Sitting comfortably with a cup of coffee. Champagne on ice.
Extremely positive meeting IMHO.
(Tho' maybe I'm biased!?)
Quote from: Left Field on Feb 20, 2026, 01:33 PMExtremely positive meeting IMHO.
(Tho' maybe I'm biased!?)
When you hear specialists on the call urging coverage for urinary biomarker tests and some specifically for Cxbladder, I dont think bias is an issue.
IMHO I don't think the meeting could have been more positive for PEB and it will be hard to imagine how Novitas could mount a credible case to refuse coverage.
But, of course...this is the USA, so anything could happen.
One interesting comment was that prostate bio-marker tests are already funded and they are not as accurate as the bladder cancer tests.
That implies that logic would suggest coverage is a rational decision.
I'm just not sure that logic or rationality applies in the US.
A few initial thoughts from the meeting:
- very hard to gauge from the presenters questions what Novitas's position will be. Didn't give anything away.
-All the panelists, some with connections to PEB/Kaiser, all had favourable positions on biomarking in general and with CXBladder.
- I was surprised at how fundamental the questions were about the base reliability and accuracy of biomarking in general. It seems very late in the process to asking such basic questions, when the answers have been in the public domain for some time.
- SO little from the presenters questions about CXBladder or Triage itself. If this was a meeting to determine re-coverage of those products why didn't it focus more on their specific clinical utility?
Overall, nothing conclusive. On the positive side, all the expert panelists were in favour of biomarking as a useful screening tool. No-one argued that they had doubts or concerns. Which is to be expected - it's in the AUA guidelines. I'm on the whole still very positive, but looks like we are in for a bit more of a wait before the decisions made. If Novitas are truly listening to the experts and AUA then I'm still very positive after today that the eventual decision will be a positive one.
Quote from: Pierre on Feb 20, 2026, 01:55 PMOne interesting comment was that prostate bio-marker tests are already funded and they are not as accurate as the bladder cancer tests.
That implies that logic would suggest coverage is a rational decision.
I'm just not sure that logic or rationality applies in the US.
Yes, that was a very pertinent comment I thought.
Quote from: LoungeLizard on Feb 20, 2026, 01:57 PM- SO little from the presenters questions about CXBladder or Triage itself. If this was a meeting to determine re-coverage of those products why didn't it focus more on their specific clinical utility?
The meeting was never about PEB products specifically, but biomarker tests in general.
Naturally, PEB will be a major beneficiary if LCD coverage is approved, as will many thousands of patients in the US.
I liked the bit of the discussion about access to care, which was an issue for one of the practising urologists who said that a patient who can't, or won't, drive 600 miles for a cystoscopy will be much more likely to go to their local clinic to give a sample for testing.
Also, by using the GP as the first port of call it takes the pressure off urologists who are also not accessible in the more remote areas of the US.
I thought it was interesting where the Chairwoman told a story about her Father in Law not wanting to have a cystoscopy but was happy to have a urine tet.
Be very interesting how PEB Management Articulate that meeting to the Market.
Happy to be holding whatever way the market reads this as I think Novitas will open a new LCD.
Quote from: Pierre on Feb 20, 2026, 02:08 PMThe meeting was never about PEB products specifically, but biomarker tests in general.
Naturally, PEB will be a major beneficiary if LCD coverage is approved, as will many thousands of patients in the US.
I thought that given the LCD is specific to cxbladder/triage, then the questions might at least cover some aspect of their specific clinical utility? I did think there might have been questions asked about Kaisers experience with CXBladder and maybe about the Strata study - the largest randomised trial for microhematuria so far.
Quote from: LoungeLizard on Feb 20, 2026, 01:57 PM- SO little from the presenters questions about CXBladder or Triage itself. If this was a meeting to determine re-coverage of those products why didn't it focus more on their specific clinical utility?
Sorry I disagree with you, I clearly heard several comments that CX Bladder was particularly important as a triage tool (both in males and females.)
(The female market potential was new to me.)
Here is Psychic's view ex other channel
Very, very positive. So positive I've cancelled my cystoscopy appointment!
The head swims with possible uptake if Triage plus adopted in the primary setting and very convincing arguments made by Panelists as to why this needs to be happening. Strong support for Cxbladder Triage plus.
Timeline now, lift trading halt Mon (tues latest) Whoosh
Feb 24th First of four medicare appeal hearings for cxbladder triage claims scheduled to begin.
TBD( say 3 months) novitas expected to publish draft LCD
45 day Public comment period follows
Final LCD late 2026 early 2027. Novitas must finalise LCD within a year of draft
Effective date 1st/2nd qtr 2027
Once final LCD published there is a 45 day notice period before policy becomes efffective.
While waiting, PEB can appeal denied claims, success in those appeals could lead to revenue recognitiona say 2nd half 2026
Triage plus price already set effective Jan 1 2026 US$1328.32 each[/i]
Quote from: Left Field on Feb 20, 2026, 02:27 PMSorry I disagree with you, I clearly heard several comments that CX Bladder was particularly important as a triage tool (both in males and females.)
(The female market potential was new to me.)
I may have missed something, but it seemed to me that it was the panelists that were trying to talk about CXBladder/Triage but that the presenters written questions didn't even mention them, but were focussed on biomarkers generally.
I guess it doesn't matter a whole lot in that the LCD will be about re-imbursing for CXBladder/Triage not as a ruling on the whole biomarking industry.
I asked ChatGPT if an LCD could be limited to specific products. Here's the answer I received:
Yes, Centers for Medicare & Medicaid Services (CMS) Local Coverage Determinations (LCDs) can be, and often are, limited to specific products, brands, or categories of items. Medicare Administrative Contractors (MACs) use LCDs to define which specific items or services are considered "reasonable and necessary" for coverage in their regions.
Health and Human Services, Office of Inspector General (.gov)
Health and Human Services, Office of Inspector General (.gov)
How LCDs Limit Specific Products:
Approved Product Lists: LCDs can restrict coverage to a, curated list of approved products (e.g., specific HCPCS codes for skin substitutes) while explicitly excluding others.
Clinical Criteria: Policies may limit coverage to products that meet stringent, evidence-based criteria, such as requiring randomized controlled trials (RCTs) for skin substitute grafts.
Category Restrictions: LCDs might only cover certain types of products (e.g., only human-derived tissue products) while excluding others (e.g., non-human or, in some proposals, liquid/gel products).[/i]
Will be interesting to read PEB's comments to market on Monday, and of course the market response. On the whole, the meeting was very positive in that the expert panellists were all clearly supportive. Pretty much what they were saying that the clinical evidence is no longer a matter of debate. They are using it as per the guidelines and finding it a useful tool. Over to you Novitas?
5-10c bounce on Monday?
Quote from: LoungeLizard on Feb 20, 2026, 03:35 PMWill be interesting to read PEB's comments to market on Monday, and of course the market response. On the whole, the meeting was very positive in that the expert panellists were all clearly supportive. Pretty much what they were saying that the clinical evidence is no longer a matter of debate. They are using it as per the guidelines and finding it a useful tool. Over to you Novitas?
5-10c bounce on Monday?
PEB's view of the meeting and their assessment of the likely outcome, and its timing, will be the key factors determining the price action after the TH is lifted - hopefully on Monday.
They won't want to be accused of overhyping the comments made in the meeting and ramping the SP.
My pick is they will be cautiously optimistic about the probability of a positive response from Novitas without being too exuberant.
Despite that, any hint of positivity in their summary is bound to lead to an initial SP surge that will quickly come back to reality. I think your 5-10c bounce is a fair estimate of where things might settle until the next news from Novitas.
https://www.nzx.com/announcements/467944 (https://www.nzx.com/announcements/467944)
Now we await the market reaction.
https://www.nzx.com/announcements/467944
Good summary IMO.
Quote from: Left Field on Feb 23, 2026, 09:41 AMNow we await the market reaction.
https://www.nzx.com/announcements/467944
Good summary IMO.
Yep, a well worded response to the meeting by Peter Meintjes.
Opened at 30.5cps.
There will be a few profit takers around today keeping a cap on the exuberance.
Quote from: Pierre on Feb 23, 2026, 10:00 AMOpened at 30.5cps.
There will be a few profit takers around today keeping a cap on the exuberance.
I've learnt to be patient thanks to you and now extremely well positioned ;) Onwards & upwards.
Looks like its going to be a good day at the office, but as noted, there will likely to be profit takers that will keep the lid on things. Also:
"Pacific Edge estimates the timelines for draft coverage are within approximately six months and final-effective coverage within a further approximately six months, noting Novitas has up to 12 months from the published draft to finalize or retire any draft LCD."
Hopefully, due to the weight of evidence and the overwhelming support of urologists, Novitas might reach a (positive) decision before then.
I wonder if PEB might look to to CR on the back of the positive vibe?
Quote from: LoungeLizard on Feb 23, 2026, 10:22 AMHopefully, due to the weight of evidence and the overwhelming support of urologists, Novitas might reach a (positive) decision before then.
I wonder if PEB might look to to CR on the back of the positive vibe?
I think PEB have a few options they are exploring (from memory they mentioned 'exploring other financing options' in one of the last updates.)
They also have a legal case proceeding for reimbursement.
If not CR then maybe partnerships, new strategic shareholders....even a listing in the USA??? Time will tell.
I have confidence in the team to get it right.
Looks like Mr Market is irrationally disappointed there wasn't an immediate decision in PEB's favour following Friday's meeting.
The "fear" of another CR will be playing on a few minds too.
It's quite clear that the comments from specialists at the meeting are grounds for cautious optimism of a positive outcome from Novitas in the months ahead - but there is still no certainty.
Only 1.7m shares have changed hands so far today as I write. It seems, that, apart from a few profit-takers, most holders are, like me, hanging on for the big announcement (one way or the other) later in the year. IMHO the odds are definitely weighted in our favour.
Agreed.
Most of the trading today will be speculators cashing their chips and leaving the table. Long term investors like us will see this through for the eventual big pay day, which does seem even more likely now from how the CAS meeting went.
Absolutely no reason to bail now, when everything seems to be - finally! - going PEB's way.
For those that may have missed this post on the NZX50 thread by Bulltrap
Quote from: bulltrap on Feb 25, 2026, 08:58 PMI took up some business with ForBar with their index commentary as a perk. Here's my take on their latest update (here (https://secure.forsythbarr.co.nz/research/library/8pqwg4Jl) if you have access):
- No changes to NZX50 or other S&P NZX indices expected
- VSL still iffy on meeting liquidity requirements, but expected to pass
- ERD is still next in line, followed by SEK, PEB, RAK and then SMI
I get the impression that ForBar doesn't know for sure if VSL passed liquidity in the Dec 2025 review. If it actually failed, it's likely it fails again, which would trigger VSL exit with ERD replacing it. Consider it an outside chance.
If ERD doesn't make it this time, I expect it'll lose its front-runner spot for the next review. It went 'parabolic' last year, and its September high of NZ$2.94 is still in the 6-month pricing window, giving it an average price (per ForBar) of $1.76. But then it literally went parabolic back to ground zero, down to around $0.90 this week. The average price is already following it down.
Meanwhile, PEB is on the resurgent, and the bull-bait case for the year is that it could regain both Medicare coverage and its spot on the NZX 50.
That said, let me make a case for SMI. Its primary listing is in Australia, so only some fraction of its free-float counts towards NZX index rankings. ForBar apparently have this fraction a bit under 25% - again, not sure if they get this from S&P or their own modelling. But I think this number is on the low side, noting that SMI's traded volume on the NZX is closer to a third of NZX+ASX, and that by mid-2024 when the NZX listing was announced over 40% (https://www.listcorp.com/asx/smi/santana-minerals-limited/news/santana-applies-to-add-new-zealand-stock-exchange-listing-3050907.html) of the share registry had NZ addresses.
The 'IWF' fraction actually used, according to the index methodology (https://www.spglobal.com/spdji/en/documents/methodologies/methodology-sp-nzx-index.pdf), comes from the number of shares registered in NZ. That's influenced by whether NZ-based investors bothered going through the tedious (and perhaps pointless) process of shunting their holdings over. I'm not aware of these numbers being available publicly, and S&P might get privileged info from the share registry (MUFG in this case) or maybe the exchanges.
(As an aside, until 2023 the IWF would've been based instead on what proportion of revenue came from NZ.)
The combined effects for SMI of an upward IWF revision, cap raisings, and further upward price moves, could easily put it in pole position for the June 2026 review.
Disc: Holding ERD through the potholes. It's been good to me in the past and my holding is all free carry. PEB likewise. Also holding SMI.
Interesting update. Bodes well for the future.
https://www.nzx.com/announcements/468522
Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces its Dunedin laboratory has signed a service agreement with Singapore General Hospital (SGH), an important milestone in the company's strategy to drive the adoption of its tests in the Asia Pacific.
Great news that Singapore General Hospital is now on board - and no involvement from Novitas!
The first step on the way to wider expansion into Asia Pacific region - this can only be seen as very positive news.
Onward and upward.
Is there a connection between the timing of this decision and the CAC contractor meeting last week. Being so close it's hard to ignore, Singapore was probably already 99 percent on board and waiting to hear how the meeting went before going public with the announcement. I'd be pleased if there is now a dominoe effect of other medical institutions. Momentum is building
Quote from: Habitz on Mar 03, 2026, 11:24 AMIs there a connection between the timing of this decision and the CAC contractor meeting last week. Being so close it's hard to ignore, Singapore was probably already 99 percent on board and waiting to hear how the meeting went before going public with the announcement. I'd be pleased if there is now a dominoe effect of other medical institutions. Momentum is building
Agreed. The medical debate is over - just need insurance providers to recognise that the urological community has moved on and are already adapting their practice to include bio-marking as a screening tool.
Singapore General Hospital's adoption of PEB"S tests could be a big deal if it helps open up the wider Asian market.
With SGH now ordering Cxbladder, does this change PEB from a speculative gamble to a genuine investment, probably not yet but it strengthens the case. Curious if others see it the same way.
Quote from: Habitz on Mar 03, 2026, 03:20 PMWith SGH now ordering Cxbladder, does this change PEB from a speculative gamble to a genuine investment, probably not yet but it strengthens the case. Curious if others see it the same way.
Still a gamble still methinks ... even with Singapore on board they haven't got the same global presence as the likes of Truscreen
Quote from: Habitz on Mar 03, 2026, 03:20 PMWith SGH now ordering Cxbladder, does this change PEB from a speculative gamble to a genuine investment, probably not yet but it strengthens the case. Curious if others see it the same way.
IMHO, PEB remains a very high risk case.
Even with the SGH agreement in place, plus inclusion in the AUA guidelines, and the support and evidence from Kaiser Permanente etc, it won't be until Novitas issues an LCD in PEB's favour that the gamble will be eliminated, or at least substantially reduced.
The chances of approval by Novitas appear to be much higher following the recent CAC meeting. However, if it doesn't occur, then it will be a very rocky road ahead for PEB and its shareholders.
I've been a shareholder and supporter since 2012, but will take whatever I can get to exit the company if Medicare coverage is denied this time.
It's still definitely a gamble.
PEB is still a gamble rather than than an "investment" but if it's success centres around the Novitas decision (which it does) you would have to say there's a greater chance than not that the gamble will pay off.
In fact, if Novitas were making their decision purely on clinical utility then the PEB tests would have a 100% chance of getting coverage.
But because Novitas have, so far, been very inconsistent and at times, downright illogical, then I would rate the chances of coverage qt around 70-80%.
Also, the upside (a positive decision) is the SP potentially rising to previous levels of $1.50 and perhaps even further. The downside (a negative decision) is the SP going back to below $10c.
In other words - it's worth the stretch ;)
Another brick in the wall.....
https://www.nzx.com/announcements/468678
"The initiation of Cxbladder testing at Townsville University Hospital marks the continued adoption of the Cxbladder suite in Australia. Globally Cxbladder is now available in the US, Australasia, and Israel and in select markets throughout Asia and South America. In the US, the test has been used by over 5,000 urologists who have ordered more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the population via public healthcare and every resident has the option of ordering the test online."
Good to see PEB has been busy diversifying & strengthening away from over reliance on USA.
The potential use of CxB in primary care was discussed at the CAC meeting in February, and now this announcement of "nurse-led services" at Townsville hospital, is further evidence that PEB products could be used as a diagnostic tool by a wider range of medical clinicians and not be limited just to urologists.
If this trend continues, the demand could expand exponentially and result in significant sales growth at a much faster pace.
PEB's future is looking brighter every day
Update attached.
https://api.nzx.com/public/announcement/470695/attachment/466248/470695-466248.pdf
This was a very positive update. Yes there are concerns around cash burn, but I see management on top of this and they indicated they have other options to raise cash instead of tapping shareholders.
I thought the information on page 6 re BCBS plans adopt policy for Cxbladder is incredibly positive for PEB.
Cxbladder Triage is now covered by two commercial payers within the Blue Cross Blue Shield(BCBS) network, a significant advance in our efforts to drive adoption of Cxbladder by commercialpayers. BCBS North Carolina (~3.4m covered lives) and BCBS South Carolina (~762k covered lives)adopted positive medical policy for Cxbladder Triage in March.
Meanwhile, Highmark, an independent licensee of the BCBS association and one of the largestBCBS plans in the US (covering 7 million lives), has adopted medical policy for Cxbladder Monitor forthe surveillance for cancer recurrence. Combined these insurers offer Pacific Edge access to a patientpopulation of 11.2 million, more than twice the populaton we reach through Kaiser PermanenteSouthern California.
The Triage medical policies mirror the coverage language from Avalon Healthcare Systems publishedin February, demonstrating the influence that positive policy with Avalon (and other third parties suchas EviCore, Carelon, Concert Genetics and ECRI) can have on future medical policy adoption amongcommercial payers1. This success validates Pacific Edge's strategic approach of establishing medicalpolicy through third parties on the back of guideline inclusion, and supported by clinical utility studies
Capital raise....... the Novitas CDC delays have made it inevitable.
https://www.nzx.com/announcements/472368
In their words....PEB "on the cusp of a commercial inflection point???" We shall see.
Yep, a CR was inevitable.
17c is just below the current level, which in my view is probably a good thing so that the SP doesn't take much of a hit, but also PEB must be confident that the support is still there.
Details of the latest cr out to raise $24m. Good news only burning through $2.4m a month so all going well no more cap raises this year. To date have spend over $300m of shareholders money to only have $11.5m of sales FY25. Net loss increased to $35m FY25. Only have $5.1m in cash as at 30th of April...
Placement offer details only a small discount and
- The Placement Offer Price will be NZ$0.170 per share representing:
- 2.3% discount to the last closing price of NZ$0.174 on 8 May 2026
- 2.0% discount to the five-day VWAP of NZ$0.17351
Will be interested to see how this cap rise goes given it's not underwritten and at such a low discount. Will shareholders keep giving it money. How much money (not freebies) has the guru ceo put in? Why did the old founder ceo sell down most of his shares when he left?
The question people should look at I think "is there better opportunities out there for your money".
I hope this company is successful but I'm sceptical. Good luck to holders though.
Quote from: Shareguy on May 11, 2026, 02:19 PMDetails of the latest cr out to raise $24m. Good news only burning through $2.4m a month so all going well no more cap raises this year. To date have spend over $300m of shareholders money to only have $11.5m of sales FY25. Net loss increased to $35m FY25. Only have $5.1m in cash as at 30th of April...
Placement offer details only a small discount and
- The Placement Offer Price will be NZ$0.170 per share representing:
- 2.3% discount to the last closing price of NZ$0.174 on 8 May 2026
- 2.0% discount to the five-day VWAP of NZ$0.17351
Will be interested to see how this cap rise goes given it's not underwritten and at such a low discount. Will shareholders keep giving it money. How much money (not freebies) has the guru ceo put in? Why did the old founder ceo sell down most of his shares when he left?
The question people should look at I think "is there better opportunities out there for your money".
I hope this company is successful but I'm sceptical. Good luck to holders though.
I think the real question to ask is "do I think Novitas are going to overturn their decision and re-instate PEB's Medicare coverage?" If the answer to that is "yes" then 17c is very good value for a share that will be 3x that within a week of the decision. If your answer is "no" then there are certainly much better places to put your money.
Quote from: LoungeLizard on May 11, 2026, 02:29 PMI think the real question to ask is "do I think Novitas are going to overturn their decision and re-instate PEB's Medicare coverage?" If the answer to that is "yes" then 17c is very good value for a share that will be 3x that within a week of the decision. If your answer is "no" then there are certainly much better places to put your money.
I definitely think Novitas will reinstate Medicare coverage, but the other question is "when will that decision be announced." With any luck we should have the wheels in motion before the end of 2026.
I am heartened by the fact that all directors are supporting the CR, with the chairman fronting up with $500k.
The CR will increase the shares on issue by ~10%. I am once again supporting a PEB CR and have submitted my application in the placement to increase my holding by 12% (that will result in a nice round number).
I'm looking forward to Lounge Lizard's forecast of (at least) a trebling of the 17cps issue price coming to fruition to reward my patience and perseverance as a shareholder since 2012.
Where did you apply for the Cap raise? I cannot find any link for it.
Quote from: 850man on May 12, 2026, 09:03 AMWhere did you apply for the Cap raise? I cannot find any link for it.
I received an email from Cameron Partners, investment banking advisers to PEB, inviting me to participate via the Share Placement scheme.
The Retail Offer opens on Thursday.
Quote from: 850man on May 12, 2026, 09:03 AMWhere did you apply for the Cap raise? I cannot find any link for it.
Sorry, I omitted to include the text from Cameron Partners email that explained the reason for applying via the Placement. Here it is:
PEB completed a separate Retail Offer in August 2025 (within the last 12 months). If you participated in that 2025 Retail Offer, there is a possibility that the maximum amount you may be able to participate in this 2026 Retail Offer is reduced below NZ$50,000 by the amount of your subscription in the 2025 Retail Offer. This is because the NZX listing rules applicable to PEB limit the amount that each PEB shareholder can participate in retail offers within 12 months of each other (in this case the 2025 and 2026 Retail Offers) to NZ$50,000 in aggregate. PEB intends to use its placement capacity under the NZX listing rules to enable such PEB shareholders to subscribe for up to NZ$50,000 in new shares under the 2026 Retail Offer, but there is a risk that PEB may have no remaining capacity under those rules following the Placement.
Therefore, if you subscribed in the 2025 Retail Offer and wish to invest again, you may be better to subscribe in the Placement, rather than waiting for the Retail Offer (to avoid any scaling required by the NZX listing rules, as applicable). There is no limit to the amount you can apply for in the Placement. The Placement will only be scaled if there is excess demand.
Quote from: Shareguy on May 11, 2026, 02:19 PMDetails of the latest cr out to raise $24m. Good news only burning through $2.4m a month so all going well no more cap raises this year. To date have spend over $300m of shareholders money to only have $11.5m of sales FY25. Net loss increased to $35m FY25. Only have $5.1m in cash as at 30th of April...
Placement offer details only a small discount and
- The Placement Offer Price will be NZ$0.170 per share representing:
- 2.3% discount to the last closing price of NZ$0.174 on 8 May 2026
- 2.0% discount to the five-day VWAP of NZ$0.17351
Will be interested to see how this cap rise goes given it's not underwritten and at such a low discount. Will shareholders keep giving it money. How much money (not freebies) has the guru ceo put in? Why did the old founder ceo sell down most of his shares when he left?
The question people should look at I think "is there better opportunities out there for your money".
I hope this company is successful but I'm sceptical. Good luck to holders though.
Good post and I agree. Forgive me, I've forgotten, is this the eight or ninth capital raise ? I've lost count. Every time I've taken notice it comes with assurances this capital raise will see us through to successful commercial operations. How many times can they cry wolf before nobody believes them anymore ?
I can not see why PEB goes to the bother of having capital raises.
Surely they would be better to have shareholders on direct debt, and just take out monthly payments from them,much like I pay my rates,insurance,power and bank card.
Quote from: lorraina on May 12, 2026, 01:12 PMI can not see why PEB goes to the bother of having capital raises.
Surely they would be better to have shareholders on direct debt, and just take out monthly payments from them,much like I pay my rates,insurance,power and bank card.
Very good lorriana ...great idea
Quote from: lorraina on May 12, 2026, 01:12 PMI can not see why PEB goes to the bother of having capital raises.
Surely they would be better to have shareholders on direct debt, and just take out monthly payments from them,much like I pay my rates,insurance,power and bank card.
Yes great idea Lorraina. Even if it does get approval how many years before it's profitable. Share prices follow earnings says the wiseman.
Forget earnings,they are unlikely to happen.Best they can every hope to achieve is ongoing employment for existing staff.
Once shareholders have seen regular monthly withdraws from their bank a/c they may think it is like Lotto .
PEB should offer a bonus to contributing shareholders.
A bit like Heart Foundation .ie a chance to win a house or car.
I would guess current capital raises would have cost PEB a house or two,every time.?
Let me put on my rose tinted glasses!
1. They get coverage reinstated later this year.
2. This leads to widespread adoption of Triage and Triage+.
3. They are cashflow positive by the end of 2028.
4. The following year they get a takeover offer at $1.25 from a multinational healthcare company.
What did I miss?
I enjoy reading the cynical comments, but let's see who's grinning this time next year.
I doubt PEB Director Anatole Masfen would have supported the previous CR with $5m, or chair Simon Flood would be putting $500k into this one, along with contributions from all other directors, if there was not a high degree of confidence in PEB's prospects of success with the current LCD review.
The AUA would not have included CxBladder in their guidelines, Kaiser Permanente would not be publishing glowing reports and Singapore General Hospital would not be endorsing the product if it did not deliver on its promises.
The vagaries of the US Health system are a nightmare to navigate but it now seems likely that the long and tortuous track could be heading towards a successful conclusion.
Nothing is guaranteed of course, but I'm optimistic and supporting them once again. However, this will be my final contribution if we dont hit the jackpot this time.
You don't have to agree with my support for PEB but I'll be happy to receive your good wishes for a good outcome for this determined New Zealand company trying to make it big on the international stage.
I was only trying to have a bit of fun.
Happy for the PEB "subscription donators" to have the last laugh..
Like everyone I would be very pleased for them to be successful.
Excellent news.
The Pacific Edge share Placement of $18 million has been very well supported and upsized to $25.4 million.
The Retail offer of $6 million (also with the right to accept oversubscriptions) opens on Thursday 14th.
Quote from: Pierre on May 12, 2026, 09:26 PMExcellent news.
The Pacific Edge share Placement of $18 million has been very well supported and upsized to $25.4 million.
The Retail offer of $6 million (also with the right to accept oversubscriptions) opens on Thursday 14th.
Circa 40% oversubscription by the institutions and large investors..... that's a great start to this Cap Raise.
Here's the relevant link FYI - https://www.nzx.com/announcements/472520
Details of retail cap raise
https://www.nzx.com/announcements/472608
Interesting to see how market interpretes this news.
Best I stick more money into CR. $0.17 looks cheap to me
Draft LCD Proposes Medicare Coverage for Triage and Triage
15/05/2026, 08:42 NZST, GENERAL
DRAFT LCD PROPOSES MEDICARE COVERAGE FOR TRIAGE AND TRIAGE PLUS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX/ASX: PEB) today notes that a draft Local Coverage Determination (LCD) with foundational medical policy for urine-based biomarkers for hematuria evaluation (DL40378) has been published to the Medicare Coverage Database, with explicit coding guidance for Cxbladder Triage and Triage Plus in the associated Local Coverage Article (LCA) (DA60424).
The draft LCD 'Urine-based Biomarkers in Patients with Microhematuria' (DL40378) establishes hematuria evaluation as a covered Medicare benefit for the first time and importantly distinguishes hematuria patients as eligible for Cxbladder Triage and Triage Plus when contrasted with the existing non-coverage LCD 'Genetic Testing in Oncology: Specific Tests' which is for a different patient population, i.e. 'patients with cancer or substantiated suspicion of cancer'.
In the rationale section of the draft LCD, Novitas states: "Given the low prevalence of malignancy in patients with MH , the limited diagnostic performance of urine cytology and earlier generation UBBs1, and the emerging body of evidence supporting select multi-analyte rule-out assays, limited coverage for UBB testing is supported when applied within a narrowly defined clinical context. Specifically, use of validated multi-analyte UBBs may be reasonable and necessary to support risk-stratification in appropriately counseled, intermediate-risk patients with MH who are considering deferral of cystoscopy."
Importantly, the associated draft article for billing and coding guidance (DA60424) makes clear that both Cxbladder Triage (0363U) and Cxbladder Triage Plus (0420U) are proposed to be reimbursable under this policy. No other urine-based biomarkers are included in the draft coding article creating a moat around our microhematuria business.
Pacific Edge Chief Executive Dr Peter Meintjes said: "This new draft LCD establishes hematuria evaluation as a covered Medicare benefit for the first time. The draft language clearly distinguishes microhematuria patients as eligible for urine-biomarker testing and notes positive coverage for Cxbladder Triage and Triage Plus. This result reflects the substantial body of clinical evidence Pacific Edge has developed in recent years and the clinical needs described by the panel of experts assembled by Novitas for its recent CAC Meeting.
"We welcome Novitas' decision to expediently address our reconsideration requests and those of the AUA and other clinicians. This is an excellent outcome for Medicare patients, urologists, and the broader healthcare system, supporting access to appropriate care while balancing clinical and economic considerations.
"The draft LCD and LCA confirm our position as the first mover and market leader in non-invasive diagnostics for microhematuria patients suspected of bladder cancer, and Pacific Edge now stands on the cusp of a major commercial inflection point with the only two tests covered for microhematuria evaluation.
"Importantly, as Triage Plus has been included in the draft coverage language, we have the opportunity to shift our customers over to i) a test with higher clinical utility, ii) a test that works on a broader range of patient types, iii) a test that continues to have a cost benefit for healthcare systems and payers, and iv) a test that shifts the economics of Pacific Edge towards operating profitably given the Medicare price of US$1,328 per test, a 75% improvement over the US$760 received for the legacy Cxbladder products," Dr Meintjes said.
While an LCD, when finalized, directly enables reimbursement for over 66 million Medicare patients, the clarity in draft coverage language provides a template for US commercial payers to adopt in their own medical policies for the 223 million US lives they collectively insure. The Company also expects this news to provide a tailwind to the adoption of our tests in international markets.
Publishing the draft LCD marks the beginning of a well-defined process governed by the Medicare Program Integrity Manual. This begins with a 'Notice and Comment' period of a minimum of 45 days during which Novitas will hold a public meeting and accept written comments. Within 12 months from today, Novitas must address the comments and publish a final version of the LCD or withdraw the draft LCD. If it finalizes the draft LCD, it will become effective 45 days after it is published.
"Noting the strength of the underlying clinical evidence, the alignment to AUA guidelines and the clinical opinion expressed on the CAC, Pacific Edge looks forward to Novitas addressing comments and publishing the final LCD," Dr Meintjes said.
"Given this draft LCD clearly distinguishes microhematuria patients as covered and as distinct from cancer patients in the non-coverage LCD (L39365), Pacific Edge will engage with Novitas to seek reimbursement for Triage and Triage Plus on a claim-by-claim basis during the draft period."
Dr Meintjes said the language in the draft LCD reflects the strength of Pacific Edge's value creation strategy that is founded on generating the compelling clinical evidence required to drive behavior change in physicians.
"We produce evidence that is founded on the frameworks of AV, CV, CU , on defined patient populations, with statistically significant sample sizes and measuring the appropriate endpoints that drive change in medical policy. Creating value for investors through evidence development is a core expertise that Pacific Edge can repeat for Cxbladder Triage Plus, for Surveillance Plus and future products beyond bladder cancer."
Pacific Edge notes that its retail offer to eligible existing shareholders to raise up to NZ$6 million, with the ability to accept oversubscriptions at Pacific Edge's discretion (Retail Offer), opened on Thursday, 14 May 2026 and closes at 5:00pm NZST on Thursday, 28 May 2026. The Retail Offer is open to "Eligible Shareholders", who are all persons recorded on Pacific Edge's share register at 7:00pm NZST on Friday, 8 May 2026 as being a holder of Pacific Edge shares and having an address in New Zealand.
The Retail Offer follows Pacific Edge's successful placement (the Placement) of NZ$25.4 million of new ordinary shares to certain investors at a price of NZ$0.17 per share, which closed on Tuesday, 12 May 2026. Over 90% of the shares to be issued under the Placement will be issued to existing Pacific Edge shareholders, who were prioritized in the Placement.
Eligible Shareholders who wish to participate in the Retail Offer are able to apply for up to a maximum of NZ$50,000 of new shares per shareholder at NZ$0.17 per share, the same price per share offered to investors under the Placement. Further information on the Retail Offer, including the Retail Offer Document that contains the terms and conditions of the Retail Offer, and information on how to apply for shares under the Retail Offer, is available at www.nzx.com and www.asx.com.au under ticker code "PEB".
The draft LCD Urine-based Biomarkers in Patients with Microhematuria (DL40378) can be accessed via the following link: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=40377
The draft LCA Billing and Coding: Urine-based Biomarkers in Patients with Microhematuria (DL60424) can be accessed via the following link: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=60423
Great news .....makes the $0 .17c cap raise a bargain.
Well done holders.
Fantastic news, a long time coming! I suspect there will be a lot more holders participating in the CR - will be considerably oversubscribed or scaled back.
Looking forward to the market reaction!
This is great news! PEB still have to turn this into revenue. The fat lady isn't singing but she's certainly clearing her throat
Champagne morning tea at PEB HQ today.
Im slightly tempted to open a bottle myself!
Match SP on opening $0.21c........
I hope PEB directors dont accept too much oversubscription in the retail CR.
They will be able to raise much more at a higher cps in the future.
30 cents at opening!
We're on our way....
Quote from: Pierre on May 15, 2026, 10:00 AMI hope PEB directors dont accept too much oversubscription in the retail CR.
They will be able to raise much more at a higher cps in the future.
30 cents at opening!
It's interesting for the draft LCD to arrive on PEB's desk a few days after the CR. On the one hand it's a shame the CR didn't happen AFTER the news (could have demanded a higher price) but on the other, it does allow current holders to participate at the much lower price (probably close to a 50% discount).
Probably just co-incidental, but I do wonder if PEB didn't perhaps orchestrate the timing as a reward for loyal investors???
Quote from: LoungeLizard on May 15, 2026, 10:08 AMIt's interesting for the draft LCD to arrive on PEB's desk a few days after the CR. On the one hand it's a shame the CR didn't happen AFTER the news (could have demanded a higher price) but on the other, it does allow current holders to participate at the much lower price (probably close to a 50% discount).
Probably just co-incidental, but I do wonder if PEB didn't perhaps orchestrate the timing as a reward for loyal investors???
PEB has no control over when Novitas make their announcements or decisions. Yep, launching the Cap raise next week would have been much better if this news had been known in advance.
Glad I bought in the placement. Will buy more in the retail offer now.
Profit takers moving in now. Will be interesting to see where the SP lands at closing today. Around 25c maybe?
I loaded the data ex PEB this morning into Gemini and got
The chances of Pacific Edge gaining finalized Medicare coverage from Novitas are exceptionally high, as the publication of a positive draft Local Coverage Determination (LCD: DL40378) and Local Coverage Article (LCA: DA60424) explicitly nominating Cxbladder tests indicates that the administrative and clinical hurdles have been largely cleared.
Probability Analysis & Strategic Outlook
Near-Certain Finalization: Draft LCDs that explicitly name and assign positive coverage to specific billing codes (0363U and 0420U) rarely get completely reversed unless significant new negative data emerges.
Exclusive Competitive Moat: No other urine-based biomarkers were included in the draft billing article, giving Pacific Edge a temporary monopoly in the US Medicare microhematuria diagnostic market.
Atypical De-risking: By separating microhematuria (MH) evaluation from standard oncology genetic testing thresholds, Novitas has permanently bypassed its previous non-coverage stance (L39365).
Revenue Inflection: Transitioning users to Cxbladder Triage Plus increases the per-test Medicare reimbursement rate from US$760 to US$1,328 (a 75% pricing premium).
Interim Commercial Operations
Claim-by-Claim Strategy: Pacific Edge will immediately target case-by-case reimbursement from Novitas using the draft text as technical justification during the evaluation period.
Private Payer Leverage: The company will use this draft language to p**** the 223 million US lives covered by commercial insurers, who typically mirror Medicare rules.
Capital Runway Secure: The financial risk of the 12-month finalization window is heavily mitigated by the newly completed NZ$25.4 million institutional placement and the open NZ$6 million retail shareholder offer.
Quote from: Pierre on May 15, 2026, 10:11 AMPEB has no control over when Novitas make their announcements or decisions. Yep, launching the Cap raise next week would have been much better if this news had been known in advance.
Glad I bought in the placement. Will buy more in the retail offer now.
I'm sure you're 100% right, but it does seem rather strange that the long awaited LCD determination (draft) happened in the same week as the CR.
Quote from: LoungeLizard on May 15, 2026, 11:09 AMI'm sure you're 100% right, but it does seem rather strange that the long awaited LCD determination (draft) happened in the same week as the CR.
Sheer coincidence IMO.
If PEB had any prior knowledge of the decision they would have waited till the LCD announcement before launching their CR. They could have raised more money at a higher issue price.
There is no logical reason for going early with the CR if they were aware this news was coming.
I'm certainly not complaining about the CR / LCD timing. The record date has passed so no johny-come-lately can pile in on the CR but it does allow long term holders to participate and get a considerable discount in doing so. Quite often CR's have negative effect on holders so it's refreshing that this one delivers an instant windfall.
Quote from: Pierre on May 15, 2026, 10:13 AMProfit takers moving in now. Will be interesting to see where the SP lands at closing today. Around 25c maybe?
Closed at 27c. A nice 59% gain on the issue price in the CR.
Lots more to come when the LCD is finalised later this year.
Very happy holder here.
Great day for holders. The negative posts from just a couple of days ago, didn't age well!
Applied for a 20% increase to my holding today - probably will be scaled back. Pretty much a no-brainer to participate in the CR given the 60% discount.
A lot of horse-trading today, but when things settle down I would expect the SP to keep increasing up to the finalisation of the LCD, which is a certainty. Lot's of good news to come - increasing tests and revenues, other providers perhaps coming on board, momentum in Asia and inclusion in the NZX50.
27c is a steal in my opinion given that PEB are in a much stronger position now than they were when the SP was $1.50!
Based on todays news, PEB could be a takeover target sooner rather than later. Once the LCD is confirmed in the future PEB has this to themselves as no other product in the LCD
Quote from: Basil on May 16, 2026, 11:46 AMMFB is in play, whereas PEB is not.
MFB is capable of paying as much as 15% gross dividend in FY28 if a takeover is not forthcoming whereas its anyone's guess when of if PEB might ever pay a dividend. MFB is much more of heads you win, tails no takeover and with huge dividends in the years ahead you win even bigger.
PEB you are living in hope just like previous shareholders over the decades have lived in hope before you.
What a laugh indeed.
Compare the addressable market for PEB cf MFB.
Compare the protective 'moat' and research that endorses PEB cf MFB.
The market is forward looking.
Quote from: Arbroath on May 16, 2026, 07:04 PMMFB will never be worth $1b+ with the potential to be worth 2-3x that. Obviously different risk profiles but I'm surprised how many can't see where PEB is not at relative to its past.
Well said.
Imminent commercial success has been promised and inferred many, many times before by PEB management and over more than 2 decades all that's happened is over and over again they keep tapping shareholders for more capital so many times with promises that this time it will be different that I have lost count. It might take many more years and several more capital raises before this company produces real earnings, if ever. Good luck to shareholders.
I totally understand your perspective Basil; it's a view that is probably shared by all non-shareholders – and perhaps even by a few who are holders. However, IMO this time IS DIFFERENT.
Last Friday's announcement of a draft LCD for urine-based biomarkers for hematuria evaluation explicitly proposes Medicare coverage for PEB's CxBladder Triage and Triage Plus. This is a hugely significant development, especially when coming so soon after the meeting of a panel of urological experts hosted by Novitas in February.
When the LCD is finalised, potentially later this year, it will provide PEB with access to reimbursement for 66 million Medicare patients. It also will encourage commercial insurers to include coverage in their policies for 223 million lives that they insure. In addition, PEB expects the news to provide a tailwind to the adoption of its products in international markets. As others have alluded to, the addressable market for PEB is enormous and achieving only a relatively small percentage will be a game changer for the business.
Not only does this latest LCD announcement herald a substantial financial opportunity for investors, but also it positions PEB on the international stage to play a significant role in helping to reduce the death rate from the over 600,000 new cases of bladder cancer diagnosed annually worldwide.
Sorry for going on a bit, but I strongly believe PEB is now on the cusp of greatness (and will achieve far more than MFB ever will). The company won't be paying a dividend anytime soon though.
Quote from: Pierre on May 17, 2026, 11:48 AMI totally understand your perspective Basil; it's a view that is probably shared by all non-shareholders – and perhaps even by a few who are holders. However, IMO this time IS DIFFERENT.
Last Friday's announcement of a draft LCD for urine-based biomarkers for hematuria evaluation explicitly proposes Medicare coverage for PEB's CxBladder Triage and Triage Plus. This is a hugely significant development, especially when coming so soon after the meeting of a panel of urological experts hosted by Novitas in February.
When the LCD is finalised, potentially later this year, it will provide PEB with access to reimbursement for 66 million Medicare patients. It also will encourage commercial insurers to include coverage in their policies for 223 million lives that they insure. In addition, PEB expects the news to provide a tailwind to the adoption of its products in international markets. As others have alluded to, the addressable market for PEB is enormous and achieving only a relatively small percentage will be a game changer for the business.
Not only does this latest LCD announcement herald a substantial financial opportunity for investors, but also it positions PEB on the international stage to play a significant role in helping to reduce the death rate from the over 600,000 new cases of bladder cancer diagnosed annually worldwide.
Sorry for going on a bit, but I strongly believe PEB is now on the cusp of greatness (and will achieve far more than MFB ever will). The company won't be paying a dividend anytime soon though.
Fully agree with this and also note that rather than encouraging other non-medicare payers, the law in many states mandates that non-medicare insurers must reimburse these tests once the lcd becomes permanent.
Im very surprised that they are still available at 27c, but maybe their history is dragging on them. They wont be at that price for long imo.
Note ex For Bar this morning
Pacific Edge (PEB) received the positive news it has been seeking. Draft Medicare/CMS reimbursement coverage for its Cxbladder Triage and Triage Plus products, meaningfully increasing its revenue outlook. The inclusion of Triage Plus is important; it wasn't previously covered and commands a ~+75% higher price than Triage. We do not expect Medicare test volumes to quickly return to prior highs, but considering: (1) this early coverage decision; (2) the potential for PEB to seek claim-by-claim reimbursements during the draft period; and (3) a steady increase in reimbursed test volumes, PEB's FY27 cash burn should be lower than its prior ~-NZ$2.5m per month target. PEB's investment case now returns to clinical adoption, revenue growth, and execution rather than the binary coverage outcome that has overshadowed it for the past four years. Revenue growth was solid when PEB last had coverage, but its EBITDA losses expanded as its investment behind this growth was greater. This time, revenue growth will need to be strong without a meaningful cost increase.
Favourable draft local coverage determination (LCD)
PEB's Cxbladder Triage and Triage Plus products have been included in a draft LCD published on 14 May 2026 (here and here). This is the outcome PEB has been aiming for and marks a return to Medicare reimbursement for Cxbladder. The inclusion of Triage Plus is important given its meaningfully higher price point. PEB's products were the only urine-based biomarkers included in the draft decision. There is still at least three months until the decision is finalised/effective and a minor chance the LCD changes by then.
Meaningfully higher revenue trajectory
PEB earnt ~NZ$17m in revenue from Medicare in FY24 when it last had coverage for its Triage product. It is likely to take time for Medicare volumes to return to previous highs, particularly given its meaningfully reduced US salesforce, but the ~+75% higher price of Triage Plus (US$1,328, not covered previously) versus Triage (US$760) should be a tailwind to future Medicare revenue. While Triage Plus doesn't have American Urological Association (AUA) guideline inclusion today, this positive coverage decision should allow PEB to transition a large share of Medicare volumes to Triage Plus in a relatively short time period.
A lower cash burn but not yet breakeven
PEB is prioritising profitability rather than growth at all costs, so we expect a gradual increase in its US salesforce from current levels (~seven) rather than rapid growth back to the >30-person headcount last time PEB had coverage. PEB's FY26 exit cost base was ~NZ$40m–NZ$45m; we expect modest growth from this level as lab volumes and its salesforce grow, but for its EBITDA losses to narrow each year. With PEB's oversubscribed capital raise (likely now >NZ$30m versus the NZ$24m expectation), and an earlier-than-expected coverage decision, PEB's capital outlook is better than expected, but we believe very strong Medicare test volumes and solid cost control would still be needed to avoid the need for more capital before PEB reaches breakeven.
Quote from: Greekwatchdog on May 18, 2026, 07:18 AMPEB's investment case now returns to clinical adoption, revenue growth, and execution rather than the binary coverage outcome that has overshadowed it for the past four years. Revenue growth was solid when PEB last had coverage, but its EBITDA losses expanded as its investment behind this growth was greater. This time, revenue growth will need to be strong without a meaningful cost increase.
If its any good why aren't the local DHB's using it ? In my own brush with the prospect of bladder cancer many years ago I asked the Urologist why they aren't using it and she said that you simply cannot beat sticking a camera up there and having a look.
Very recently I've been supporting my best mate who passed blood in his urine and ended up getting a huge 5 cm cancer growth removed from his bladder. Its been a two year journey with so many cystoscopy's he's lost count and thankfully he has just been given the all clear but there is an established program of follow up inspections. Importantly at no point has it ever been mentioned or suggested that he will be using a biomarker such as PEB's test in any aspect of his treatment or follow up checking.
From my own personal experience, (I doubt many shareholders have this personal experience to draw upon), and supporting my mate a lot over the last two years in his experience I suspect clinical adoption will be a LOT slower than many shareholders would like and ongoing cash burn a lot higher. Its not a cheap test nor is it 100% reliable by any stretch of the imagination. PEB have it all ahead of them in the years ahead to prove they can become firstly, cash flow break even and then secondly, generate real and consistent earnings.
It could me many years, if ever before PEB can prove they can generate real earnings on a much expanded cost base. I think the company is best described as still being highly speculative.
Sorry to hear that you and your mate have been/are dealing with bladder cancer.
Many District Health Boards do use Cxbladder.
Here's what Gemini says:
New Zealand public healthcare providers have been adopting Pacific Edge's non-invasive bladder cancer tests since MidCentral DHB became the first to utilize it in 2013. Over the years, the technology's coverage has expanded across multiple regions.
Key Details & Coverage
Regional Access: Regions including Canterbury, Waitematā, Counties Manukau, Capital & Coast (Wellington), Taranaki, and Northland have formally adopted the suite of tests into their standard of care.
Testing Pathway: The tests are used to triage patients presenting with microhematuria (blood in the urine) and to monitor for the recurrence of bladder cancer.
Patient Benefit: Testing allows healthcare providers to assess risk via a non-invasive urine sample, helping many patients avoid the discomfort and cost of a cystoscopy.More than half of the New Zealand population has access to the test.
Quote from: Basil on May 18, 2026, 10:14 AMIf its any good why aren't the local DHB's using it ? In my own brush with the prospect of bladder cancer many years ago I asked the Urologist why they aren't using it and she said that you simply cannot beat sticking a camera up there and having a look.
Very recently I've been supporting my best mate who passed blood in his urine and ended up getting a huge 5 cm cancer growth removed from his bladder. Its been a two year journey with so many cystoscopy's he's lost count and thankfully he has just been given the all clear but there is an established program of follow up inspections. Importantly at no point has it ever been mentioned or suggested that he will be using a biomarker such as PEB's test in any aspect of his treatment or follow up checking.
From my own personal experience, (I doubt many shareholders have this personal experience to draw upon), and supporting my mate a lot over the last two years in his experience I suspect clinical adoption will be a LOT slower than many shareholders would like and ongoing cash burn a lot higher. Its not a cheap test nor is it 100% reliable by any stretch of the imagination. PEB have it all ahead of them in the years ahead to prove they can become firstly, cash flow break even and then secondly, generate real and consistent earnings.
It could me many years, if ever before PEB can prove they can generate real earnings on a much expanded cost base. I think the company is best described as still being highly speculative.
DHB's are using CXBladder -at last count I think over half are using it covering over 60% of the population. It is being rolled out progressively so I would expect all will make it available at some point.
A cystoscopy is still the gold standard and CXBladder is not designed to replace it. It is simply a screening tool to prevent unnecessary cystoscopies. Rather like the PSA test to detect prostate cancer.
Quote from: Pierre on May 18, 2026, 10:23 AMSorry to hear that you and your mate have been/are dealing with bladder cancer.
Thanks mate, it was a long time ago for me, about 15 years ago from vague memory.
Quote from: LoungeLizard on May 18, 2026, 10:29 AMA cystoscopy is still the gold standard and CXBladder is not designed to replace it. It is simply a screening tool to prevent unnecessary cystoscopies. Rather like the PSA test to detect prostate cancer.
Indeed, although deeply uncomfortable, especially with a pretty young trainee watching, (it was never smaller if you know what I mean), I was very grateful to promptly have the gold standard inspection and got a clear result. I'm surprised it was never mentioned as an option for my friend either. We both commenced with the same issue albeit at different times in our lives, blood in the urine. I've been very impressed with the thoroughness and timeliness of the treatment's my friend has received in the public health system and thankfully he's come through the journey well. A 5 cm growth in your bladder is huge and it was an incredibly stressful experience for him. Anyone who's supported a close friend through a cancer journey knows its quite exhausting for support people too.
His and my experience makes me genuinely wonder where the PEB test fits into the local DHB system, (and what the uptake rate will be with US healthcare providers), as its not a cheap test like a blood test for PSA and of course a blood test covers off a huge range of other risk factors. I just haven;t seen the use of it in real world conditions and can't see how such an expensive test is really useful relative to the cost of a cystoscopy, (which at the time I had mine done I asked the Urologist and she said they are working on an all inclusive cost of $NZ1,500), it could be considerably more now.
Quote from: Basil on May 18, 2026, 10:47 AMThanks mate, it was a long time ago for me, about 15 years ago from vague memory.
Indeed, although deeply uncomfortable, especially with a pretty young trainee watching, (it was never smaller if you know what I mean), I was very grateful to promptly have the gold standard inspection and got a clear result. I'm surprised it was never mentioned as an option for my friend either. We both commenced with the same issue albeit at different times in our lives, blood in the urine. I've been very impressed with the thoroughness and timeliness of the treatment's my friend has received in the public health system and thankfully he's come through the journey well. A 5 cm growth in your bladder is huge and it was an incredibly stressful experience for him. Anyone who's supported a close friend through a cancer journey knows its quite exhausting for support people too.
His and my experience makes me genuinely wonder where the PEB test fits into the local DHB system, (and what the uptake rate will be with US healthcare providers), as its not a cheap test like a blood test for PSA and of course a blood test covers off a huge range of other risk factors. I just haven;t seen the use of it in real world conditions and can't see how such an expensive test is really useful relative to the cost of a cystoscopy, (which at the time I had mine done I asked the Urologist and she said they are working on an all inclusive cost of $NZ1,500), it could be considerably more now.
I listened to the CMS coverage public hearing earlier in the year. One thing thing that stuck with me was that at least two of the clinicians made the point that something like 90% of patients presenting with haematuria never went anywhere near a urologist - especially women. This was for various reasons, shortage of urolgists, geographical location etc etc. The point being that the biggest opportunity for PEB technology isn't competing with cytoscopy -it is competing with doing nothing - and that is a huge market opening IMO. DYOR of course but I've taken a big position and will look forward to some nice dividends in due course.
Quote from: Poet on May 18, 2026, 11:02 AMThis was for various reasons, shortage of urolgists, geographical location etc etc.
Not sure this holds water. This suggests the US healthcare system is in worse shape than the N.Z. which seems incredibly unlikely to me other than the fact that we have a public system and they don't so cost could be a serious factor in the US for the average American so I asked A.I. what is the average cost for a cystoscopy procedure in the US and here's the answer
QuoteThe cost of a cystoscopy procedure in the USA typically ranges from $1,000 to $3,000.
That's not materially different to the cost of the PEB test so I'm not convinced. Any intelligent person knows you're better off with the gold standard warrant of fitness inspection...but then again, maybe there's lots of unintelligent people in the US, that's definitely a plausible explanation seeing as they voted "Chump" into power for a second time. Agree, a lot of people do nothing when blood presents in the urine or take antibiotics and hope its just a urinary track infection but doing something further means making a choice between a very expensive urine marker test or a cystoscopy. I'm not convinced the uptake of a urinary biomarker is the go to option and the reason is the not inconsiderable cost. If it was a few hundred dollars compared to a cystoscopy that cost ten times that much I would be convinced but clearly we're very far from that being the case.
Quote from: Basil on May 18, 2026, 11:13 AMNot sure at all this holds water. This suggests the US healthcare system is in worse shape than the N.Z. healthcare system which seems incredibly unlikely to me other than the fact that we have a public system and they don't so cost could be a serious factor in the US for the average American so I asked A.I. what is the average cost for a cystoscopy procedure in the US and here's the answer That's not materially different to the cost of the PEB test so I'm not convinced. Any intelligent person knows you're better off with the gold standard warrant of fitness inspection...but then again, maybe there's lots of unintelligent people in the US, that's definitely a plausible explanation seeing as they voted "Chump" into power for a second time. Agree, a lot of people do nothing when blood presents in the urine or take antibiotics and hope its just a urinary track infection but doing something further means making a choice between a very expensive urine marker test or a cystoscopy. I'm not convinced the uptake of a urinary biomarker is the go to option and the reason is the not inconsiderable cost. If it was a few hundred dollars compared to a cystoscopy that cost ten times that much I would be convinced but clearly we're very far from that being the case.
There's a huge amount of data on the Pacific Edge website about the cost savings to providers, patient satisfaction surveys, the greater access to care for patients living in remote areas of the US, as well as all the positive clinical trials that resulted in the tests getting included in the UAU guidelines and now re-instated for Medicare coverage. Kaiser Permanence (the biggest non-profit provider in the US) has a huge database of real world data showing the big drop in unnecessary cystoscopies (and savings) as a result of using CXBladder.
In other words, investors like myself and others here have looked at all this data, weighed up the risk and reward and decided it was worth a punt. It's been a bit of a rough ride but the stars are aligning now for PEB and the market is starting to get on board. PEB is clearly not for everyone, but I wouldn't be surprised if it doesn't turn out to be the best NZX50 performer this year.
Fair enough LL. At least you called it what it is, a punt.
Everything that's gone before with PEB and everything they've said before and my own experience makes me deeply skeptical. Good luck ro holders.
I should clarify that PEB was definitely "a punt" back in the day when it was still conducting clinical trials, gathering clinical support and trying to win back Medicare coverage. Now that all those things have been put to bed, there's a lot less risk involved, although obviously nothing is certain.
All investments are involve a degree of speculation. I wouldn't, for example, touch MFB with a barge pole because of its history and high degree of vulnerability to economic downturn. Horses for courses.
Some companies have a well proven track record of earnings and growth and are VASTLY lower risk than a company that has yet to prove anything in terms of earnings. MFB has proven its business model is very resilient and is about to report improved earnings in an extremely tough economy. All PEB has proven so far is it can tear up ~ $300m+ in shareholders capital and make endless promises of imminent commercial success which to date have all proven to be false dawns.
It remains to be seen if it can ever generate a single cent in earnings. Maybe this time it will be different and maybe this weekend I will have a punt on Lotto and win knowing that at least the staff at the Lotto shop are not eating 99.9% of my speculative wager unlike some other companies offering the chance of a spin on the roulette wheel.
But why stop there, you can punt on the gambling machine itself, SKC trading at an all time low of 56 cents today. Their 10 year chart is a shocker just like PEB's. There's a difference between investing and speculating mate although the line is somewhat blurred with SKC but I would suggest the line is very clear between MFB and PEB.
Nice that ANZ investments see value in PEB.....
https://api.nzx.com/public/announcement/472822/attachment/468632/472822-468632.pdf
Quote from: Basil on May 18, 2026, 02:21 PM....... I would suggest the line is very clear between MFB and PEB.
Well said...... this pic shows your clear line very well. lol.
There is really no relevant comparison between these two companies... other than in your mind............ time to move on.
A lot of negative talk about the need for another cap raise next year to aid commercialisation. I see things going in a different direction - more along the lines of selling a strategic stake to a partner that can fund and accelerate commercialisation.
Chat GPT had this to say
With the draft LCD now explicitly covering Cxbladder Triage and Triage Plus, Pacific Edge has moved from being a speculative reimbursement story to a potential commercialization story. That changes the type of partner that becomes attractive.
The most logical partners fall into four groups:
1. Large Diagnostics Companies
These are the highest-probability strategic partners because they already have the sales force, payer relationships and laboratory infrastructure needed to scale Cxbladder.
Potential candidates:
Abbott Laboratories
Roche Diagnostics
Quest Diagnostics
Labcorp
Danaher (Cepheid/Beckman)
Why:
The draft LCD creates a reimbursement pathway for 66+ million Medicare beneficiaries and potentially provides a template for commercial payers.
Pacific Edge currently has a highly focused bladder cancer franchise rather than a broad oncology menu.
Larger diagnostics groups often acquire or partner with companies once reimbursement risk is substantially reduced.
2. Urology-Focused Strategic Partners
These may be the best commercial fit.
Examples:
Kaiser Permanente
Urology America
US Urology Partners
Pacific Edge already has significant experience with Kaiser, and the company has highlighted growth through the Kaiser Southern California system.
A large urology network could accelerate adoption without a full acquisition.
3. Precision Oncology Companies
Less obvious, but potentially high value.
Examples:
Exact Sciences
Guardant Health
Natera
Rationale:
These companies are building cancer-testing platforms.
Cxbladder gives them a strong position in urology, where many have limited exposure.
Exact Sciences is particularly interesting because it has a history of paying significant premiums for reimbursed cancer diagnostics assets.
4. Commercial Payers and Population Health Groups
Not acquirers, but important strategic allies.
Pacific Edge has already reported coverage progress with:
Blue Cross Blue Shield North Carolina
Blue Cross Blue Shield South Carolina
Highmark
Avalon Healthcare Solutions
These organizations have either adopted or endorsed coverage criteria for Cxbladder products, which could help drive broader payer adoption.
Who would I rank highest?
If the draft LCD becomes final substantially unchanged, my ranking would be:
Rank Potential Partner Strategic Logic
1 Quest Diagnostics Immediate national distribution
2 Labcorp Similar rationale; strong physician reach
3 Exact Sciences Strong oncology fit and acquisition history
4 Abbott Laboratories Scale and global reach
5 Roche Diagnostics Global molecular diagnostics leader
For shareholders, the most interesting outcome is probably not a distribution agreement but a takeout. The draft LCD significantly reduces the largest historical objection to acquiring Pacific Edge: reimbursement uncertainty. The company's own commentary describes the draft policy as placing it "on the cusp of a major commercial inflection point" and establishing a moat around the microhematuria market because only Triage and Triage Plus are included in the draft coding guidance.
If the final LCD arrives in late 2026 with similar wording, I think Quest, Labcorp and Exact Sciences become the three most plausible strategic counterparties to watch.
Quote from: Poet on May 23, 2026, 11:00 AMA lot of negative talk about the need for another cap raise next year to aid commercialisation. I see things going in a different direction - more along the lines of selling a strategic stake to a partner that can fund and accelerate commercialisation.
Chat GPT had this to say
With the draft LCD now explicitly covering Cxbladder Triage and Triage Plus, Pacific Edge has moved from being a speculative reimbursement story to a potential commercialization story. That changes the type of partner that becomes attractive.
The most logical partners fall into four groups:
1. Large Diagnostics Companies
These are the highest-probability strategic partners because they already have the sales force, payer relationships and laboratory infrastructure needed to scale Cxbladder.
Potential candidates:
Abbott Laboratories
Roche Diagnostics
Quest Diagnostics
Labcorp
Danaher (Cepheid/Beckman)
Why:
The draft LCD creates a reimbursement pathway for 66+ million Medicare beneficiaries and potentially provides a template for commercial payers.
Pacific Edge currently has a highly focused bladder cancer franchise rather than a broad oncology menu.
Larger diagnostics groups often acquire or partner with companies once reimbursement risk is substantially reduced.
2. Urology-Focused Strategic Partners
These may be the best commercial fit.
Examples:
Kaiser Permanente
Urology America
US Urology Partners
Pacific Edge already has significant experience with Kaiser, and the company has highlighted growth through the Kaiser Southern California system.
A large urology network could accelerate adoption without a full acquisition.
3. Precision Oncology Companies
Less obvious, but potentially high value.
Examples:
Exact Sciences
Guardant Health
Natera
Rationale:
These companies are building cancer-testing platforms.
Cxbladder gives them a strong position in urology, where many have limited exposure.
Exact Sciences is particularly interesting because it has a history of paying significant premiums for reimbursed cancer diagnostics assets.
4. Commercial Payers and Population Health Groups
Not acquirers, but important strategic allies.
Pacific Edge has already reported coverage progress with:
Blue Cross Blue Shield North Carolina
Blue Cross Blue Shield South Carolina
Highmark
Avalon Healthcare Solutions
These organizations have either adopted or endorsed coverage criteria for Cxbladder products, which could help drive broader payer adoption.
Who would I rank highest?
If the draft LCD becomes final substantially unchanged, my ranking would be:
Rank Potential Partner Strategic Logic
1 Quest Diagnostics Immediate national distribution
2 Labcorp Similar rationale; strong physician reach
3 Exact Sciences Strong oncology fit and acquisition history
4 Abbott Laboratories Scale and global reach
5 Roche Diagnostics Global molecular diagnostics leader
For shareholders, the most interesting outcome is probably not a distribution agreement but a takeout. The draft LCD significantly reduces the largest historical objection to acquiring Pacific Edge: reimbursement uncertainty. The company's own commentary describes the draft policy as placing it "on the cusp of a major commercial inflection point" and establishing a moat around the microhematuria market because only Triage and Triage Plus are included in the draft coding guidance.
If the final LCD arrives in late 2026 with similar wording, I think Quest, Labcorp and Exact Sciences become the three most plausible strategic counterparties to watch.
Interesting. I wouldn't necessarily favour a buyout myself - at least not in the early stages - but a strategic partnership with a bigger company with the funds and influence to fast-track take-up, both in the US and globally would be a positive outcome.
Included in today's FY results report:
...final effective coverage of the LCD
expected by the end of the 2026 calendar year.
Novitas confirms, post
balance date, that Pacific Edge can commence claim-by-claim reimbursement for
intermediate risk microhematuria patients in line with the draft LCD.
Looks like 2026 will be PEB's year!
Detailed FY26 Financial results and related info...........
https://api.nzx.com/public/announcement/473221/attachment/469219/473221-469219.pdf
Press release re above
https://www.nzx.com/announcements/473221
The significant increase in the Medicare pricing together with the news "that products covered in the draft are eligible for claim-by-claim reimbursement for the patient population defined in the draft LCD," should see revenue increasing almost immediately. Agreed, Pierre, that 2026 is looking like a transformative year for PEB.
Looks like retail holders will have there application scaled back. Not surprising.
Cancer diagnostics company Pacific Edge (NZX/ASX: PEB) today reminds shareholders that the retail offer to eligible existing shareholders to raise up to NZ$6 million (with the ability to accept over-subscriptions at PEB's discretion) closes at 5.00pm NZT on Thursday, 28 May 2026 (Retail Offer).
The Retail Offer is open to "Eligible Shareholders", who are all persons recorded on Pacific Edge's share register at 7:00pm NZST on Friday, 8 May 2026 as being a holder of Pacific Edge shares and having an address in New Zealand. Eligible Shareholders can subscribe for up to NZ$50,000 of new shares under the Retail Offer.
As at 8am on 25 May 2026, PEB has received applications for $14.0 million under the Retail Offer.
The news of the volume of applications and likely scaling should give the SP a bit of a kick upwards today.
6/14 is 42 percent if oversubs are not accepted
Looks like there will be massive scaling for retail investors to keep PEB within capital raise regs. Seems unfair to me that PEB, knowing the cap raise limits, still accepted oversubscription for Institutions and as a result retail investors get heavily scaled back.
You would think that with their history of capital raises they would get it right.?
Quote from: lorraina on May 26, 2026, 11:39 AMYou would think that with their history of capital raises they would get it right.?
I guess the unexpected news they received midway thru the Cap Raise with the opening of the LCD is the main reason for oversubscription.
Not a bad reason for those who were invested when offer opened. Investors trying to get as much as they can. Would they have if the news of LCD Draft had not come thru?
Quote from: Greekwatchdog on May 26, 2026, 11:47 AMI guess the unexpected news they received midway thru the Cap Raise with the opening of the LCD is the main reason for oversubscription.
Not a bad reason for those who were invested when offer opened. Investors trying to get as much as they can. Would they have if the news of LCD Draft had not come thru?
Yes, the great news in the middle of the cap raise would have made certain that it would be way oversubscribed. PEB couldn't have foreseen that. And I guess, whatever amount retail investors do get, they stand to make a 60% gain. Can't complain I guess :)
Harbour been buying PEB at an average of .20c
https://api.nzx.com/public/announcement/473443/attachment/469508/473443-469508.pdf
Smart people at Harbour.
Quote from: Left Field on May 27, 2026, 05:32 PMHarbour been buying PEB at an average of .20c
https://api.nzx.com/public/announcement/473443/attachment/469508/473443-469508.pdf
Smart people at Harbour.
Probably bought most of them at 17c in the Placement, then topped up with a few more on the market to achieve that average.
I bought in the Placement and got all I requested. I also have applied for the maximum in the Retail offer but obviously expect to be substantially scaled.
Quote from: Left Field on May 27, 2026, 05:32 PMHarbour been buying PEB at an average of .20c
https://api.nzx.com/public/announcement/473443/attachment/469508/473443-469508.pdf
Smart people at Harbour.
Wonder what their average price is now?
Mind you they banked big profits when share price was about 130
It will be interesting to see how the $6m Retail CR unfolds.
As at 8am Monday applications totalled $14m and probably reached $16-18m by last night.
The $18m Placement was oversubscribed by ~40% so it would be unfair to smaller holders if a similar uplift wasn't applied to the Retail offer before scaling.
PEB will end up with somewhere around $31-33m in the piggy bank following this CR. This should give them the opportunity to get moving rapidly as soon as the LCD is confirmed later this year.
Game on!