PEB - Pacific Edge Ltd

[snigmac]

I was thinking similar. If it was a definite no you'd think they would just say so. You would hope the Urologists in the US are requesting it. What troubles me is the corrupt nature of the US medical system and what competing treatments are doing in the background.

In the event of a shutout you'd think PEB would be a likely takeover target for a big US player with pockets deep enough to get its suite of treatments across the line.

Discl; Holding

There were some pretty strong comments from C21 and the Urology community. These comments (written and verbal) are new (I think) and make the scenario different to that in 2023. Who knows tho, heck maybe CrowdStrike will push the decision past 27 July 2024 😆.

[pierre]

I posted this comment late this afternoon on the Stocktalk site:

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!

[snigmac]

I posted this comment late this afternoon on the Stocktalk site:

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!

Why do you think that a negative outcome is highly likely?

[pierre]

Why do you think that a negative outcome is highly likely?

The vagaries of the American health system don't fill me with confidence that PEB will be able to maintain coverage. I just feel there will be much arse covering by the Novitas decision makers to justify their current stance on the product. That doesn't mean PEB will never gain coverage, but I'm sure Novitas will require more clinical evidence, lengthy independent trials, or find some other tactics to justify sticking to their position. I just can't see them backing down in favour of a little ol' company from Noo Zealand.

I hope I'm 100% wrong, though and will be delighted if I am. (Maybe I'm just trying to prepare for the worst while hoping for the best?)

[snigmac]

Yes back to flipping a coin.

The following article indicates that US states have regulated to allow for biomarkers to be covered: https://open.substack.com/pub/sensit...utm_medium=web

Relevant part as follows :

Twenty states have now passed laws that require biomarker tests to be covered by their state’s insurance providers. The bills cover not just cancer, but any disease for which a biomarker test improves accurate diagnosis

[850man]

Yes back to flipping a coin.

The following article indicates that US states have regulated to allow for biomarkers to be covered: https://open.substack.com/pub/sensit...utm_medium=web

Relevant part as follows :

Twenty states have now passed laws that require biomarker tests to be covered by their state’s insurance providers. The bills cover not just cancer, but any disease for which a biomarker test improves accurate diagnosis

That is positive however the laws also state:

"These bills require insurers to pay for the tests if they are

1. Prescribed by a physician, and
2. Are cleared by the FDA, recommended in practice or national guidelines, or covered by local or national Medicare / Medicaid."

Unfortunately CXB fails to meet the criteria on point #2.

Disc: Holding more than any sensible person should be

[snigmac]

Technically if coverage is maintained, then point #2 is satisfied?

[etrader]

If PEB don’t get coverage they say there’s enough cash burn to work on rolling out cashflow outside this Medicare, or until it gets coverage in the future, am I reading it correct that if they don’t they will take the legal angle hoping to overturn this downstream.

Around 50 mill cash currently around 18 months remain, not forgetting ANZ chucked $75 odd mill some years back so I’m sure many would be keen for this to get accepted.

If no I’m guessing share price .03c to .05 on day one, if yes you could easily see 20c plus

Technically if coverage is maintained, then point #2 is satisfied?

[snigmac]

My understanding is that if PEB don't get coverage, the appeals and next steps for PEB depend on how the final LCD is worded and what is covered. For example, if coverage is lost and Novitas has not considered the Strata information, PEB could ask for the new Strata information to be considered which could potentially trigger coverage for another 12 months. If the lcd is finalized in a way where the LCD is not new information and coverage is lost, I think the price will tank to 5-6cents from 8 cents atm.

If coverage is kept, or there is a further extension or the lcd is withdrawn, PEB is likely going to bounce to 25c or higher.

I still think the lcd is fundamentally flawed and should be withdrawn with more consultation with stakeholders. The support from 21c and AUA and etc are quite strong.

Disclosure- the risk is real. I have a fair bit of funds stuck in PEB.

[Roskat]

Medical Device Coverage and the FDA

FDA’s principal role in medical device coverage is to evaluate the safety and effectiveness of medical devices for use in the United States. In general, after the FDA’s approval or clearance of a device, other organizations—for example, payors and the professionals who provide health care (providers)—decide whether to cover, pay for, use, or recommend a device.
Payors include government payors such as the Centers for Medicare & Medicaid Services(CMS), private health plans, health technology assessment groups, and others who provide input into coverage, procurement, and reimbursement decisions.
Data that medical device manufacturers submit to FDA to demonstrate the safety and effectiveness of a medical device may not always overlap with the data needed by payors to make coverage determinations. As a result, there may be a delay or denial in coverage, payment, and use of a device after it has been approved or cleared. Some decisions may ultimately delay patient access to medical devices. By communicating with payors early, manufacturers may be able to design their clinical trials to produce the data required for regulatory authorization and for positive coverage determinations, which may expedite patient access. Not only do patients and manufacturers benefit from this approach, but also payors benefit as it allows them to horizon-scan and be better prepared for novel medical devices in the pipeline.