PEB - Pacific Edge Ltd

[snigmac]

My concern is with Novitas' ego. They cocked up the initial funding removal because they failed to follow process. This second round is really about following process. Do they want egg on their faces if it also shows they made a bad call 1st time to cut funding? As a supplier to the US government, I'd say not.

But if PEB meet guideline requirements in future and there is weakish indicative information on this now, is it a matter of egg on face now or egg of face in e.g. 2 or 3 years time? How would Novitas dispute the research that has been completed and supported?

[850man]

But if PEB meet guideline requirements in future and there is weakish indicative information on this now, is it a matter of egg on face now or egg of face in e.g. 2 or 3 years time? How would Novitas dispute the research that has been completed and supported?

Agree, the STRATA study is compelling and it would appear accepted by the AUA. I would say Novitas would be getting it right to continue to fund CXB as they can go back to the US government and show savings and improvements in patient outcomes. A double win for them. Let's hope it plays out that way

[kiora]

"Urine Tests Could Be 'Enormous Step' in Diagnosing Cancer"
https://www.medscape.com/viewarticle...&impID=6539588

[davflaws]

"Urine Tests Could Be 'Enormous Step' in Diagnosing Cancer"
https://www.medscape.com/viewarticle...&impID=6539588

Nothing about bladder cancer or the Pacific Edge Suite.

[850man]

Nothing about bladder cancer or the Pacific Edge Suite.

The author almost seems out of touch with the topic. Urine tests have been around and is use for some time, she almost reports it as revolutionary.

[bulltrap]

Interesting to see that there's 5M shares on offer for $0.195. But at almost twice the market price it doesn't seem likely to trade any time soon.

Presumably with a holding that large, it'd be an institutional player who knows what they're doing.

Does anyone have a read on the tea leaves? Could this be a big boy convention for signalling an acceptable price for a buyout perhaps?

(I'm not sure if offers like this are unusual, as Jarden Direct depth only shows me the first 15 price points.)

[snigmac]

I don't think 5m shares is a huge number. If PEB keeps Medicare cover, the price of this share will fly to around 25c minimum at least with more upside. All the institutions would be aware that this one is abit of a gamble with huge upside.

[Roskat]

The lawsuit filed against the FDA by the American Clinical Laboratory Association and HealthTrackRX focuses on challenging the FDA's plan to regulate laboratory-developed tests (LDTs) as medical devices. Here are the main points, key arguments, and requests for action from the plaintiffs:
Main Points

1. Historical Regulation: LDTs have historically been regulated under a separate framework, the Clinical Laboratory Improvement Amendments (CLIA), which did not involve the FDA's device-oriented regulatory framework. The plaintiffs argue that LDTs are services performed by skilled professionals, not tangible medical devices that are manufactured and sold.
   
2. FDA Overreach: The FDA's new rule seeks to redefine LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), a move that plaintiffs argue exceeds the FDA's statutory authority. They contend that Congress has never granted the FDA the authority to regulate LDTs in this manner.
   
3. Impact on Healthcare: Plaintiffs argue that the FDA's regulation would dramatically disrupt laboratory operations by imposing device approval requirements on tests that are currently under a different regulatory regime. This could hinder innovation, increase costs, and delay the availability of new LDTs, adversely affecting patient care.

Key Arguments

1. Statutory Overreach: Plaintiffs claim the FDA's actions are contrary to law and exceed its statutory jurisdiction, arguing that LDTs are not "devices" under the definitions provided in the FDCA. They assert that these are professional services rendered using various tools, not products distributed in commerce.
   
2. Administrative Overreach: The rule is described as arbitrary and capricious under the Administrative Procedure Act. The plaintiffs argue that the FDA has not justified the reclassification with substantial evidence and that the move does not consider the actual operation and context of LDTs in clinical settings.
   
3. Impact and Practicality: The imposition of medical device regulations on LDTs is argued to be not only beyond the FDA's authority but also impractical and harmful, risking critical diagnostic services and potentially harming public health due to reduced access to essential tests.

Requests for Action

1. Injunction and Vacatur: Plaintiffs request the court to vacate and set aside the FDA’s final rule. They seek a declaratory judgment that the rule is unlawful and an injunction to prevent the FDA from implementing or enforcing the rule.
   
2. Declaratory Relief: The plaintiffs are seeking a judicial declaration that the FDA does not have the authority to regulate LDTs as medical devices and that its attempt to do so via the final rule is invalid.
   
3. Judicial Review: The plaintiffs invite the court to review the FDA's rule under the standards of the Administrative Procedure Act to determine its legality and appropriateness under federal law.

In summary, the lawsuit focuses on defending the historical regulatory distinction between LDTs and medical devices, challenging the FDA’s statutory interpretation and its practical implications for healthcare services. The plaintiffs are seeking a court order to halt the FDA’s reclassification of LDTs as medical devices, arguing it is beyond the agency’s authority and would negatively impact the healthcare system. (end AI)

[snigmac]

Around 7 weeks until we have certainty on Medicare coverage unless a decision is made beforehand.