PEB - Pacific Edge Ltd

[Minerbarejet]

Why would you build a new lab in anticipation of an influx of Asian and Oz customers if you had no idea of when that might happen?

[psychic]

I just do not understand why they did not / could not instigate this sort of clinical study years ago with the Vets, or whoever.. (KP not interested?)

Maybe we and the AUA would have the evidence now instead of forever reading "further evidence required" in the conclusions of independent reviews.

Or will this be a case of too small (n 426 patients) and too late/ slow to give Monitor the legs it needs now before Assure MDX et al gain traction?

Four (free?) tests each at time of monitoring cystoscopy over 12 -24 month period, then collate, review and review some more a few years after final test....), publish, could be looking at 4- 5 years before this will any help?

Good they have the cash reserves to keep plodding on

[psychic]

Hopefully it's not going to retrace to 0.62 support level on the charts!!? Ouch!

It was overpriced at .30 then gapped on four puffy announcements which sent it to the moon - just in time for the big CR and to allow LT backers to recover loses and reduce. Well played. All imho.

[thegreatestben]

Making the call to back out on this, can't see the upcoming results making any significant increase to the SP.
Walking away with my original buy in, would have had a bit more in it if we hadn't taken part in the CR.

[Minerbarejet]

I just do not understand why they did not / could not instigate this sort of clinical study years ago with the Vets, or whoever.. (KP not interested?)

Maybe we and the AUA would have the evidence now instead of forever reading "further evidence required" in the conclusions of independent reviews.

Or will this be a case of too small (n 426 patients) and too late/ slow to give Monitor the legs it needs now before Assure MDX et al gain traction?

Four (free?) tests each at time of monitoring cystoscopy over 12 -24 month period, then collate, review and review some more a few years after final test....), publish, could be looking at 4- 5 years before this will any help?

Good they have the cash reserves to keep plodding on

Its not rocket science to figure out that cash in large lumps, which has been lacking up until the large cash raise, may be required for clinical studies.

Other outfits proposing their particular brand of treatment will have the same costs involved in providing similar data and may take just as long to get it.

There is a very high bar to get to the same level as cxBladder and very little wriggle room for superiority.

Even so with 800,000 patients being monitored for recurrence several times a year in the US there would be plenty of room for all contenders at the top providing they were able to match cxBladder's performance and prove it.

Getting standard of care status would certainly restrict other contenders for some time to come.

PEB are not ever going to capture the entire market and 10% would probably do nicely for PEBs continued existence, further clinical trials and other product development.

Makes you wonder what the other 90% will be doing in the meantime, doesnt it?

[Maxtrade]

It was overpriced at .30 then gapped on four puffy announcements which sent it to the moon - just in time for the big CR and to allow LT backers to recover loses and reduce. Well played. All imho.

Sadly I think you have hit the nail on the head. It's all so manipulated

[Maxtrade]

Making the call to back out on this, can't see the upcoming results making any significant increase to the SP.
Walking away with my original buy in, would have had a bit more in it if we hadn't taken part in the CR.

Unfortunately we have had to do the same, greatly reduced our holdings to reduce downside exposure. The risk reward at this time is too great. Makes more sense to sell out, then buy back in once/if there is any real traction and progress with real data/figures. Downside SP trend stronger than any upside potential currently. Don't want to be caught in a large sell off after following update if it is not a substantial uplift (which is unlikely). May well see some likeminded trades and a continued downwards push on SP prior to update.

[psychic]

Its not rocket science to figure out that cash in large lumps, which has been lacking up until the large cash raise, may be required for clinical studies.

It's not rocket science to work out that the marginal cost of processing (in this case) 1700 tests in order to validate the thing and get it in the guidelines is sweet FA surely?

[psychic]

PEB are not ever going to capture the entire market and 10% would probably do nicely for PEBs continued existence, further clinical trials and other product development.

Makes you wonder what the other 90% will be doing in the meantime, doesnt it?

No mystery at all! The gold standard will continue until a test is produced that betters it. Cxbladder clearly does not, but might in the meantime be used as an adjunct to improve management. The question is, in which circumstances and how often?

[psychic]

Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.

The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:

Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.

Guidelines current March 2021
https://www.nccn.org/professionals/p...df/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.

Deal with Kaiser June 2020

PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP

July 2020 LCD by CMS

Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary

https://www.cms.gov/medicare-coverag...d=38388&ver=13

The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bl...sive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.

April 2021 United Healthcare covers Cxbladder

Well, they don’t, really. More exaggeration.

United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency

These were the four announcements I referred to in my post earlier today (I posted this a year ago). Will be interesting to see how these announcements have driven revenue when results are pblished soon...