PEB-Pacific Edge

[Left Field]

Blood on the streets.

[LoungeLizard]

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.

[Shareguy]

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.



 

[BlackPeter]

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.

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.

[Left Field]

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.)

[Shareguy]

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. 

[Left Field]

Thanks Shareguy, impressive response by PEB IMHO.

[Basil]

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. 

If you do well you might get a new teak deck out of it.    Management already have theirs's

[LoungeLizard]

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.

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.

[Left Field]

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.

Exactly and ditto for me too!

[davflaws]

Exactly 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

[Basil]

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. 

[Shareguy]

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."

[LoungeLizard]

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. 

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. 

[Shareguy]

$.55