PEB-Pacific Edge

[Left Field]

- 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.)

[Greekwatchdog]

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]

[LoungeLizard]

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.)

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.

[Pierre]

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]

[LoungeLizard]

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?

[Pierre]

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?

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.

[LoungeLizard]

https://www.nzx.com/announcements/467944

[Left Field]

Now we await the market reaction.

https://www.nzx.com/announcements/467944

Good summary IMO.

[Pierre]

Now 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.

[Pierre]

Opened at 30.5cps.
There will be a few profit takers around today keeping a cap on the exuberance.

[Left Field]

Opened 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.

[LoungeLizard]

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?

[Left Field]

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?

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.

[Pierre]

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.

[LoungeLizard]

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.