PEB - Pacific Edge Ltd

[LEMON]

Just curious, I was speaking with a friend whose partner was a financial buff and was hired into the company to help the sale of a huge wine company in Europe, that of which we would all be familiar with the name.

[LEMON]

Demi has held senior leadership roles since 2004. Her most recent role was as Head of Operations of the Children
Medical Research Institute in Australia. Previous to this, her roles included Program Director – Executive Strategy
Delivery for Firmenich SA in Switzerland; and Program Manager - APAC Network Transformation for Caterpillar in
Australia.

More senior roles being filled for future growth.

[Snow Leopard]

... Transformation for Caterpillar. ....

Impressive.

[850man]

Demi has held senior leadership roles since 2004. Her most recent role was as Head of Operations of the Children
Medical Research Institute in Australia. Previous to this, her roles included Program Director – Executive Strategy
Delivery for Firmenich SA in Switzerland; and Program Manager - APAC Network Transformation for Caterpillar in
Australia.

More senior roles being filled for future growth.

Addition of a number of senior roles, let's hope this is all funded and more by increased revenue. Guess we'll have to wait until 27th to find that out

[Greekwatchdog]

This is all about setting up for the future. 27th is just a date where we will get a loss. How big anyones guess. $10/12m?? This role will be paid out in FY22 figures on wards

[LEMON]

Agree, personally don't mind a fall of the SP on the 27th to have a chance to pick up a few more cheap shares.
It all about the future.

The research and work is done.
Now it's all about building the team for future growth potential and getting established in the markets.

[silu]

Everyone here is talking about a loss which would indicate that the price wouldn't move much downwards when they eventually announce it right?

[Greekwatchdog]

It will do what the buyers/sellers do.

[Minerbarejet]

The SP at the end of the month will reflect the markets attitude to the extent that the cashflow has improved.

I dont think there is much doubt that it has improved but if the hiring of additional management at the current rate is anything to go by it could be an indication of a considerable improvement.

[psychic]

Hey 850 man, did you think about PE's replies to what I had posted?
To me, they agree with 3 of 4.
And I'm not convinced about the 4th (CMS)

My observations in italics, Pacific Edge comments in red
I know it is boring to wade through some of this stuff but worth thinking about as a shareholder, just sayin.

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.

NCCN Guidelines: The inclusion of urine molecular tests for UC markers into the NCCN
guidelines in 2019 is specifically for follow up of high-risk NMIBC with level 2B evidence,
as indicated. This inclusion language is a departure (improvement) from previous
versions which explicitly excluded the use of urinary UC markers for all follow up
patients. The use of urinary UC markers is specifically referenced in the NCCN review
language and collectively refers to those biomarker tests assessed in the 2015 Review
paper by Chou et al. which includes Cxbladder.

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

Kaiser Permanente (KP): The commercial arrangements of the relationship with KP are
confidential however as stated, the agreement covers all of the available Cxbladder
products. You are correct that the initial clinical evaluation of Cxbladder by KP was in a
hematuria evaluation setting and we would have expected this to translate to KP
adopting Cxbladder Triage, however KP indicated that they wished to introduce
Cxbladder into their organisation in the follow up surveillance setting to start with. This
is their decision and entirely understandable since it allows KP clinicians to maintain
contact with their bladder cancer patients as they socialise the Cxbladder technology
within the organisation (clinicians and patients alike). We have every expectation that
KP will at some point publish their hematuria study data and in time will also extend their
adoption of Cxbladder into the hematuria evaluation setting, but ultimately that is their
decision.


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.

July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
LCD’ which was in circulation for consultation. The final published LCD is L35396 and
the exclusion language relating to Cxbladder you refer to was removed following
submissions from Pacific Edge and other parties such that now the only requirement for
reimbursement by CMS is the use of valid CPT codes and the statement of medical
necessity. Medical necessity is determined by the referring physician and does not
require that Cxbladder is used instead of cystoscopy, since in most cases Cxbladder is
used in addition to cystoscopy in the US. Provided these criteria are met (which they are
for all CMS patients) Pacific Edge is receiving 100% (full) reimbursement for claims
within 40 days of claim submission. As we noted in the newsletter and at the half year,
CMS related tests accounted for a significant proportion (~67%) of our commercial test
throughput in the US for the first half of FY21 – this is quite different from the ‘very few’
you suggest.

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

United Healthcare: As stated in the newsletter and as announced to the NZX United
Healthcare have commenced coverage of Cxbladder in the Medicare Advantage
policies. We have provided you with a link to their policy. View Full Policy - PDF (page
2 of 52).