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  1. #19281
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    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.
    Last edited by LEMON; 04-05-2021 at 10:29 AM.

  2. #19282
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    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.

  3. #19283
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    Quote Originally Posted by LEMON View Post
    ... Transformation for Caterpillar. ....

    Impressive.
    om mani peme hum

  4. #19284
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    Quote Originally Posted by LEMON View Post
    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

  5. #19285
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    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

  6. #19286
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    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.

  7. #19287
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    Everyone here is talking about a loss which would indicate that the price wouldn't move much downwards when they eventually announce it right?

  8. #19288
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    It will do what the buyers/sellers do.

  9. #19289
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    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.

  10. #19290
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    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).

  11. #19291
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    My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?

  12. #19292
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    Quote Originally Posted by psychic View Post
    My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?
    I guess we will know with a bit more clarity in couple of weeks. Either way I don't see them delivering the dough in a substantial way from these announcement till starting FY2022.

  13. #19293
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    Quote Originally Posted by psychic View Post
    My question is, given these announcements have driven the SP, and you have no other proof od adoption, is the current SP warranted?
    Who knows?

    I remain a shareholder and I am positive about the future because.

    A. The test costs about $100 and sells for $ 1000 approx
    B CX way less invasive than cystoscopy
    C Insurers will save money.
    D very large market potential

    PEB is speculative but in my view has huge potential but we will have to wait 2 years at least before we see substantial growth and some profitability.
    Last edited by Brain; 06-05-2021 at 05:50 PM.

  14. #19294
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    Can I unpack and comment on these responses for you then.

    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.

    Use of urinary biomarkers went from explicity excluded to "may use" as an adjunct in high risk nmibc surveillance only, with the weakest 2b recommendation. Yes, Cxbladder was one of the tests mentioned by Chou et al who came up with conclusion that Urinary biomarkers should not be used. You will find no support there, from memory the study was critical of both results and bias of available studies.
    (ie studies funded by Pacific Edge). At best it is mentioned in passing.

    Implying to the market that Cxbladder was now part of the clinical pathway seems downright misleading to me.

    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.

    So they don't argue. The much ramped Triage review was a flop, no acknowledgement about this to market. Odd for a Company on the podium for Investor relations. Maybe KP are concerned about imaging being the adjunct as Minerbarejet is, I don't know.
    But okay, hopefully they will adopt in time. KP have been looking into ways they can reduce unnecessary cytoscopies for many years.
    We have no evidence of uptake of Monitor at this stage, sure is taking a long time to bed into the KP system or however it was PE explained the lag

    July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
    LCDÂ’ 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.

    L35396 does not seem to mention Cxbladder at all but will take PE’s word for it that the Monitor and Detect tests are included in the approved Novitas schedule which I cannot access but the LCD references. But the draft we have is certainly not supportive and so that must have been a very convincing argument by PE to have the final policy contradict this. Some proof would be nice.

    For me it comes back to this“medically necessary” requirement then, the part I struggle to have confidence in most. Cxbladder is largely being used as an adjunct to cystoscopy. The physician must be able to certify that the test is necessary when the AUA say they should not and the NCCN guidelines offer the weakest “may use” as an adjunct (and for monitoring high risk NMIBC only)

    If they are able to demonstrate in the financial results 100% reimbursement of all CMS tests as this reply suggests then I will be happy that they are making the progress they claim – regardless of my wild interpretation of the guidelines. I will try work out an estimate of what that should mean later…

    "Medically necessary" implies
    (a) it is in accordance with nationally accepted standards (ie The AUA / NCCN guidelines)
    (b) It is clinically appropriate and effective
    (c) Not primarilly for personal comfort or convenienceof patient or physician

    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).

    They agree. CxBladder is only covered by United under its Medicare Policy, not those it underwrites itself.
    Aside from the tricky notion they present that United are aboard and all their customers have access to Cxbladder, then seemingly it is only for those under Medicare, only as an adjunct in surveillance of high risk NMIBC, only when considered medically necessary.

    We will see.
    Last edited by psychic; 07-05-2021 at 12:41 PM.

  15. #19295
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    Given that the Medicare covers most of the population over 65 and Bladder Cancer as a disease falls mainly in that group I would suggest they (United) may find it "medically unnecessary" to include all the others.

  16. #19296
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    Quote Originally Posted by Minerbarejet View Post
    Given that the Medicare covers most of the population over 65 and Bladder Cancer as a disease falls mainly in that group I would suggest they (United) may find it "medically unnecessary" to include all the others.
    Then why exclude those outside this group, why hasn't United covered Cxbladder under its own policies?

    United cover only those in that group under Medicare. Medicare say tests are covered if medically necessary. Medically necessary means must be recommended under clincal guidelines. Clinical guidelines say maybe(?) use tumour markers as an adjunct in surveillance of high risk non muscle invasive bladder cancer only (otherwise do not use).

    How many tests do you reckon?

  17. #19297
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    Quote Originally Posted by psychic View Post
    Then why exclude those outside this group, why hasn't United covered Cxbladder under its own policies?

    United cover only those in that group under Medicare. Medicare say tests are covered if medically necessary. Medically necessary means must be recommended under clincal guidelines. Clinical guidelines say maybe(?) use tumour markers as an adjunct in surveillance of high risk non muscle invasive bladder cancer only (otherwise do not use).

    How many tests do you reckon?
    "Tens of thousands"



    You did ask.

    With all the shenanigans over Covid how do you follow clinical guidelines if you cant get into the clinic to follow them?
    Last edited by Minerbarejet; 09-05-2021 at 12:40 PM.

  18. #19298
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    Quote Originally Posted by Minerbarejet View Post
    "Tens of thousands"



    You did ask.

    With all the shenanigans over Covid how do you follow clinical guidelines if you cant get into the clinic to follow them?
    Haha, yes, several tens of thousands perhaps.

    And a fair question that, I have no idea but I'm going to guess that Covid or no Covid, Urologists are still turning a coin through cysto's.

  19. #19299
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    Quote Originally Posted by psychic View Post
    Haha, yes, several tens of thousands perhaps.

    And a fair question that, I have no idea but I'm going to guess that Covid or no Covid, Urologists are still turning a coin through cysto's.
    I would expect the insurance companies will get pissed off with the Urologists taking the more expensive option. Both the insurance companies and the patients will be in PEB’s corner.

  20. #19300
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    Quote Originally Posted by Brain View Post
    I would expect the insurance companies will get pissed off with the Urologists taking the more expensive option. Both the insurance companies and the patients will be in PEB’s corner.
    Can't agree, the US Insurers are not in PEB's corner yet, Cxbladder is investigational only and not covered. They will always need to follow gold standard. It is simply not a Cystoscopy vs Cxbladder test thing in the US yet, Cxbladder is only an adjunct in Surveillance, and an expensive one at that.

    I've never really understood the price point around the tests tbh. Perhaps if the tests were a tenth of the price and on high volume they might have become mainstream as an excellent adjunct to both Cytology and cystoscopy years ago? So many promising tests being developed these days, price will become an issue sooner or later.

    I'd question if a cystoscopic exam is more expensive than Cxbladder atm. Not my understanding.
    Last edited by psychic; 09-05-2021 at 04:01 PM.

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