PEB-Pacific Edge

[Greekwatchdog]

Here it is, trading halt. Info attached

https://api.nzx.com/public/announcement/467848/attachment/462723/467848-462723.pdf

[Pierre]

Here it is, trading halt. Info attached

https://api.nzx.com/public/announcement/467848/attachment/462723/467848-462723.pdf

Effective from start of trading today so no chance for last minute buying before the CAC meeting.

Now we wait for the meeting and the release of PEB's report on the content. Monday's trading will be interesting!

[850man]

Those who want to listen in to this Medicare CAC meeting. It starts midday today NZT and is estimated to run for two hours and is accessible to the public by registering at the link below.
https://fcso.webex.com/weblink/register/red3f833b75a2f3922d04ada5d71a6aee
I registered just now and got an immediate approval through. Good luck to all faithful holders

[Habitz]

No chance for last minute selling if have cold feet

[Pierre]

I'm into Webex on my phone and am now on standby waiting for the meeting to start.
It seemed a bit of a drama getting connected (maybe my fault) but I recommend accessing the system early so you dont miss any of the action.

[LoungeLizard]

I'm into Webex on my phone and am now on standby waiting for the meeting to start.
It seemed a bit of a drama getting connected (maybe my fault) but I recommend accessing the system early so you dont miss any of the action.

Worked fine from my laptop. Sitting comfortably with a cup of coffee. Champagne on ice.

[Left Field]

Extremely positive meeting IMHO.

(Tho'  maybe I'm biased!?)

[Pierre]

Extremely positive meeting IMHO.

(Tho'  maybe I'm biased!?)

When you hear specialists on the call urging coverage for urinary biomarker tests and some specifically for Cxbladder, I dont think bias is an issue.

IMHO I don't think the meeting could have been more positive for PEB and it will be hard to imagine how Novitas could mount a credible case to refuse coverage.

But, of course...this is the USA, so anything could happen.

[Pierre]

One interesting comment was that prostate bio-marker tests are already funded and they are not as accurate as the bladder cancer tests.

That implies that logic would suggest coverage is a rational decision.

I'm just not sure that logic or rationality applies in the US.

[LoungeLizard]

A few initial thoughts from the meeting:
- very hard to gauge from the presenters questions what Novitas's position will be. Didn't give anything away.

-All the panelists, some with connections to PEB/Kaiser, all had favourable positions on biomarking in general and with CXBladder.

- I was surprised at how fundamental the questions were about the base reliability and accuracy of biomarking in general. It seems very late in the process to asking such basic questions, when the answers have been in the public domain for some time.

- 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?

Overall, nothing conclusive. On the positive side, all the expert panelists were in favour of biomarking as a useful screening tool. No-one argued that they had doubts or concerns. Which is to be expected - it's in the AUA guidelines. I'm on the whole still very positive, but looks like we are in for a bit more of a wait before the decisions made. If Novitas are truly listening to the experts and AUA then I'm still very positive after today that the eventual decision will be a positive one. 

[LoungeLizard]

One interesting comment was that prostate bio-marker tests are already funded and they are not as accurate as the bladder cancer tests.

That implies that logic would suggest coverage is a rational decision.

I'm just not sure that logic or rationality applies in the US.

Yes, that was a very pertinent comment I thought.

[Pierre]

- 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?

The meeting was never about PEB products specifically, but biomarker tests in general.

Naturally, PEB will be a major beneficiary if LCD coverage is approved, as will many thousands of patients in the US.

[LoungeLizard]

I liked the bit of the discussion about access to care, which was an issue for one of the practising urologists who said that a patient who can't, or won't, drive 600 miles for a cystoscopy will be much more likely to go to their local clinic to give a sample for testing.
Also, by using the GP as the first port of call it takes the pressure off urologists who are also not accessible in the more remote areas of the US.

[Greekwatchdog]

I thought it was interesting where the Chairwoman told a story about her Father in Law not wanting to have a cystoscopy but was happy to have a urine tet.

Be very interesting how PEB Management Articulate that meeting to the Market.

Happy to be holding whatever way the market reads this as I think Novitas will open a new LCD.

[LoungeLizard]

The meeting was never about PEB products specifically, but biomarker tests in general.

Naturally, PEB will be a major beneficiary if LCD coverage is approved, as will many thousands of patients in the US.

I thought that given the LCD is specific to cxbladder/triage, then the questions might at least cover some aspect of their specific clinical utility? I did think there might have been questions asked about Kaisers experience with CXBladder and maybe about the Strata study - the largest randomised trial for microhematuria so far.