PEB-Pacific Edge

[Basil]

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.

[Shareguy]

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

[LoungeLizard]

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 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.

[Highgate]

Read the following for added context
http://equityespresso.com.au/pacific-edge-fda-update/

[Basil]

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.

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.

[LoungeLizard]

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.

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

[Hectorplains]

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.

[Left Field]

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 .

[850man]

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

[Left Field]

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

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."

[LoungeLizard]

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    

[Pierre]

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    

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.

[Crackity]

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.

Hmmmm - do you possibly have holders bias? And no disrespect intended - it's at an interesting juncture

[Pierre]

Hmmmm - 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.

[850man]

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.