Think you might be right .. averaging down or a bargain near or under NTA ?
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ANZ still gobbling them up https://www.nzx.com/announcements/423550
Anz injected $22 mill back in 2020 at 65c then shortly after it spiked to $1.55 then drifted down to the lows, agree they will be securing their average down and I’d be surprised if they keep throwing good money after bad.
Chatting to my broker when the bad news came out they had just over 2 years of funds if the current cash burn continued so they would have tried to reduce some costs in the USA around new staff etc to minimise cash burn.
I’ve invested on and off for 12 years and it definitely had potential to turn big but has taken ages to break through.
It almost needs a major pharmco to grab 20% like J & J where they can scale it to mainstream but those firms around cancer space will have watched hoping they can scoop it up for $10 mill
FOR IMMEDIATE RELEASE
Jan. 18, 2024
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Dora Hughes, M.D., M.P.H., acting chief medical officer and acting director of the Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according to the Centers for Disease Control and Prevention (CDC). For example, results from laboratory tests can be the sole determinant of whether a patient with cancer gets a particular therapy, potentially risking the patient’s life with an inaccurate test result. Because of the important role of laboratory tests in healthcare decisions, it is essential to ensure these tests work.
While the U.S Food and Drug Administration (FDA) actively oversees tests made outside laboratories by test manufacturers, tests made and run within a single laboratory, known as laboratory, developed tests or LDTs, are often used without such oversight. The FDA’s approach was developed half a century ago when tests made and used in single labs were generally simple, often made to address local individual needs, and mostly manufactured in small volumes. Therefore, the FDA, as a policy approach, generally did not enforce requirements for LDTs. However, since then, LDTs have evolved. Due to the increased risk to patients, it is time to reconsider this approach.
In recent decades, the FDA has identified concerns with a number of LDTs. For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism and Alzheimer’s Disease.1,2 Other evidence, including published literature3,4,5,6,7,8 and the FDA’s experience with tests to diagnose COVID-19,9 suggests that the situation is getting worse. Therefore, in October of this year, the FDA issued a notice of proposed rulemaking to help ensure the safety and effectiveness of LDTs by phasing out the FDA’s current approach to LDTs. If finalized, LDTs would generally fall under the same enforcement approach as other tests. The Centers for Medicare & Medicaid Services (CMS) supports the FDA’s proposal.
Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. The FDA and CMS both provide oversight to help assure the accuracy of test results, however, they have different roles. CMS regulates laboratories that perform testing on individuals in the U.S. through the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by establishing quality standards for all laboratory testing to help ensure the accuracy, reliability and timeliness of patient test results. In 2013, CMS published a fact sheet on LDTs, outlining each agency’s authority and the complementary roles of the two regulatory schemes. That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight.
Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony, CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.
The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs. LDTs play an important role in healthcare, but when they perform poorly or are not supported by science, they put patients at risk. The current approach has enabled some tests to enter the market with unfounded claims of innovation. These claims can mislead the public, undermine legitimate competition and disincentivize responsible, science-based innovation. Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.
We are now emerging from a global pandemic that has underscored the importance of accurate and reliable tests. Patients and providers need to have confidence that laboratory tests work. We believe the complementary FDA and CMS frameworks are both critical to assuring patients can rely on the clinical accuracy of their test results.
Wow ....what does it say and mean
Quarterly update is due anytime. I am expecting it next week.
Interesting update. 15% fall in tests but half the commercial team from 34 to 17. Gotta stop the bleeding. I actually like it.
The way I see it there are two main points in this, first, does the test work and give you the information claimed. FDA say they should be assessing this and approving. Secondly, are your labs up the the standards. CMS should look after this side.
This has probably all been driven by the Novitas stance with the FDA now coming to the party effectively saying this shouldn't be funder driven, this should be clinically driven. We've dropped the ball, thanks for bringing it to our attention, here's how we going to approach this moving forward. This is probably a good thing as it maintains a certain standard and gives physicians some assurance of quality. Lets just hope for the PEB shareholders, PEB has already engaged in dialogue with the FDA and CMS. Once this is completed I would have thought Novitas would then fund any FDA approved test.
Downsizing in both respects
http://nzx-prod-s7fsd7f98s.s3-websit...093/411290.pdf
I think PEB need to cross the FDA hurdle as top priority if they want to continue in the US market. They have done all they can with Novitas, that is now out of their hands. FDA have approved tests that are far less effective in terms of specificity, NPV and PPV so FDA approval of CXB is entirely possible. The potential future Novitas outcome is funding approval for FDA approved tests. I think this is highly likely.
I think I’m more confused than what PEB were
http://nzx-prod-s7fsd7f98s.s3-websit...100/411297.pdf
I had a bit of spare time so went looking for the FDA proposal. As far as I can see, in the FDA proposal https://www.federalregister.gov/docu...eveloped-tests , the date by which they want to go live with the new process is 1 April 2028 (hopefully not an April fools joke). Looks like this is to provide companies time to understand requirements, submit everything they need etc etc.
This is a few years away and raises the question as to what happens with funding in the meantime and what approach will Novitas take while this is being sorted. In a ideal world Novitas would come out with a list of approved tests, CXB included, covered until this date, or they might just leave it all up in the air.
In my opinion after reading this, this isn't about dealing with legitimate tests (hopefully like CXB), rather it sounds like the lack of regulation has allowed a large number of less than sound labs to open and offer some perhaps less than scientifically sound tests with some questionable ethical behavior.
https://scholar.google.co.nz/scholar...&pos=0&folt=kw
AUA has just reviewed Guidelines for use of Urine Tumour Markers but sadly Cxbladder still not recommended. Hope in the future for Cxbladder Monitor perhaps on further evidence.
Not great....
From an article today in UroToday "The authors also stated that the future directions of novel urinary biomarkers held promise, citing the CX Bladder platform as an example of how advances can be made in the sensitivity of detecting high-grade NMIBC" Article here http://www.urotoday.com/center-of-ex...er-cancer.html
Ai getting in on the act now.
https://scholar.google.co.nz/scholar...&pos=0&folt=kw
Small study but impressive results. Models led to 0.977 sensitivity, 0.972 specificity, and 0.973 accuracy values for the blood samples, and 0.987 sensitivity, 0.829 specificity, and 0.953 accuracy values for the urine (KCl) samples
Sunday, February 4, 2024
Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment
HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here.
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf
Topics include:
- Prohibitive costs of the rule
- Poor presentation of LDT risks and no presentation of LDT benefits
- Deeply flawed economic analyses
- Multiple categories of costs ignored and underestimated
- Existing regulatory framworks are ample
- FDA lacks statutory authority
- Elaborate statutory discussion
The letter makes a point I have made, the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##
Lengthy but worth the post I guess
Sunday, February 4, 2024
Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment
HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
###
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here.
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf
Topics include:
- Prohibitive costs of the rule
- Poor presentation of LDT risks and no presentation of LDT benefits
- Deeply flawed economic analyses
- Multiple categories of costs ignored and underestimated
- Existing regulatory framworks are ample
- FDA lacks statutory authority
- Elaborate statutory discussion
The letter makes a point I have made, the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38). ##
The 58 page report. https://www.thefdalawblog.com/wp-con...-12-4-2023.pdf
Vision of the Future under FDA LDT Regulation (White Paper)
The FDA's impending LDT rule, slated for finalization in April 2024, ushers in a transformative shift in the regulatory landscape for laboratory-developed tests (LDTs), bringing them under the same stringent oversight as in vitro diagnostics (IVDs). This comprehensive rule, aimed at safeguarding patient safety and ensuring diagnostic excellence, presents a critical juncture for laboratories utilizing LDTs and life science tools and diagnostic companies whose products form the backbone of LDT workflows. To effectively navigate this regulatory transition, life science tools and diagnostic companies must embark on a proactive strategy, encompassing reassessing their product portfolios, enhancing regulatory and clinical development capabilities, adhering to stringent quality standards, and maintaining close engagement with regulatory authorities. By embracing this proactive approach, they can effectively adapt to the FDA's LDT rule, positioning themselves for success in the rapidly evolving diagnostic landscape and eventually emerge as industry leaders in the dynamic clinical diagnostics arena.
Very Brief Blog: FDA Sends Final LDT Rule to White House
Header: FDA Sends Finalized LDT Rule to White House OMB/OIRA
##
Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024. Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).
About the Author
https://blogger.googleusercontent.co...03A8604.BQ.JPGBruceBruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.
Friday, March 8, 2024
In Writing: My Prediction for FDA LDT, 2024-2031
It was big news in the past week that FDA has sents its final LDT rule to the White House for final sign-off and publication.
https://www.discoveriesinhealthpolic...final-ldt.html
I'm putting my official multi year policy forecast in writing. Here. Click to enlarge.
Discussion.
https://blogger.googleusercontent.co...ME%20YEARS.png click to enlarge
First, for simplicity, I'm leaving the initial FDA timelines as published in Fall 2023, but I think it is very likely (80%) then will all advance by one year. Regardless, the court case will start immediately.
Second, I think there is a 95% (really, 100%) chance this will tie up in court for several years. Allow 2024 for federal court, 2025 for appeals court, and 2026 if not easily 2027 for Supreme Court.
Third, at Supreme Court, while I am not an attorney, I give a 50% chance the regulation will be tossed out as agency overreach and lack of clear Congressional text governing LDTs. I give a 10% chance that in 2026 or 2027, it will undergo further legal circling like being remanded to a lower court.
This leaves a 40% chance of the regulation being turned back on and its engine revved in 2027 or so.
Fourth, I predict, as in my initial white paper in October 2023, that the rule will have to bog down in several years of delays and deferrals if not worse. By 2029 or 2030 this will lead people to dust off VALID or other alternatives.
##
Offline.
Other possibilties include a 2nd Trump administration that might reverse the rule in a 90-day rulemaking (or un-rulemaking) cycle. Or might more subtly decline to defend it assertively in the court pathway, raising the chance it loses in court.
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Slip sliding away and not looking good now !!
Alot of the brokers have bet that the LDT decision will be finalized (in favour of PEB losing funding) and that the price will keep slipping :/
https://quoteapi.com/resources/da986...iPT0K1uBY8zt38
And it looks like two of the directors (including the Chairman) agree so they are quitting.
Bye bye …
Published: 03.13.2024Ranking Member Cassidy Seeks Information from Stakeholders on Regulation of Clinical Tests
WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information from stakeholders on ways to improve regulation of clinical tests in the United States.
Clinical tests are essential health care resources, informing 70 percent of all clinical decisions through diagnosis, screening, staging, and managing of diseases and medical conditions. Since 1976, there have been no significant reforms to the regulation of clinical tests, even as new, innovative tests are being used in health care settings.
Recent efforts by the Food and Drug Administration to unilaterally pursue regulatory reforms through rulemaking go beyond its statutory authority and threaten patient access to timely care. Cassidy rebuked the Biden administration’s executive overreach and its attempt to bypass Congress on this matter.
Cassidy hopes to use the feedback on how Congress can modernize current regulations to support innovation while ensuring these clinical tests are safe and effective to use. The deadline to submit feedback is April 3, 2024.
Read the full request here or below.
To Interested Parties:
Clinical diagnostics play a critical role in our health care system, influencing nearly 70% of all health care decisions. Diagnostic technologies are also the cornerstone of precision medicine and personalized therapies, and as such warrant oversight to ensure regulators are facilitating their continued progress, safety, and accuracy.
Stakeholders and policymakers broadly recognize the need for reform to the regulatory frameworks that oversee laboratory services and diagnostic products. In the nearly 50 years since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices, advancements in in vitro diagnostic (IVD) technologies have necessitated improvements to this framework to support timely patient access to safe and effective diganostics, especially those intended for special or rare disease populations. At the same time, clinical laboratory medicine has evolved in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted, demanding standards that reflect advancements in molecular and genomic testing and ensure appropriate oversight over these tests.
In the past, Congress has considered proposals to bring needed reforms to diagnostics regulation. These efforts have been unsuccessful and have resulted in missed opportunities to implement substantive updates to both regulatory frameworks. To further guide ongoing discussion of these matters, I welcome your insights on the following topics, specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics. Please submit any responses to diagnostics@help.senate.gov by April 3, 2024.
A mention of CXBladder as part of in-home care at a recent meeting of the South Eastern Section of the AUA https://www.urotoday.com/conference-...er-cancer.html
I'm surprised that Novitas hasn't released a decision yet, it's almost as they want to stretch the coverage.
On March 21, 2024, the House Energy & Commerce committee held a 3-hour hearing on the FDA's plan to regulate LDTs. Here are some resources, including a Zip file with all major documents.###The three hour session is online at YouTube here:https://www.youtube.com/watch?v=sQOYPjdTMzU(The YouTube program notes give access to an online YT auto transcript).The House home page for the hearing
Is there any indication of how long the hearings will take to wrap up? Is there any chance that they won't be able to conclude the matter until after July 2024, in which case the LCD might not be able to move forward and would be automatically canceled after July 2024?
With both CMS and then perhaps the FDA getting in the way of commercial uptake of cxbladder, Pacific Edgecmight not be too happy with this study just released:
https://www.sciencedirect.com/scienc...89537024001457
We know that Cytology and cystoscopy remain the gold standard in diagnosis of bladder cancer. Cytology is highly specific but lacks sensitivity, and hence the development of tumour markers such as cxbladder.
Well these clever fellows have used Ai to improve analysis of cytology and the results after a four year large cohort study suggest significant improvement in sensitivity, above that of Fish and Cxbladder.
As with all these things, further studies are needed but I am really starting to think that we have missed the boat here
A lot of the commentary about the efficacy of CXB references the original test suite. The enhanced CXB tests are a step up in sensitivity and NPV / PPV. NPV on CXB+ is 100%. That said, I'm not sure how much the enhanced tests are being promoted by PEB. A lot hinges on the Novitas outcome
Latest qr test numbers holding steady but cannot read anything into this as imo PEB's future is out of its hands for now !
Yes - ten years back? I think the accumulated losses are $200m+?
The information in the investor update looks good. I wouldn't be surprised if Novitas let the LCD laspse and then trigger another LCD after to keep PEB on their toes to produce data.
The following (shareholder newsletter) should be a significant step on the ladder for PEB. Front and centre at the largest and most influential gathering of urologists on the planet. (discl. Holding)
A ground-breaking study demonstrating the clinical utility of Cxbladder is to be the centrepiece of Pacific Edge’s activities at the 2024 American Urological Association (AUA) Annual Meeting to be held May 3 – 6 in San Antonio, Texas.
The AUA Annual Meeting represents a unique opportunity for Pacific Edge to highlight the findings of the new STRATA study and drive the adoption of Cxbladder tests. The conference, now in its 119th year, is the largest and most influential event in the US and global urological calendar, and is expected to attract over 10,000 urologists, urologic oncologists, researchers, educators, advanced practice providers, and other healthcare professionals from across North America and around the world.
STRATA, the first ever randomized controlled trial of a urine biomarker for hematuria evaluation, demonstrates Cxbladder Triage can help clinicians to safely and more effectively risk-stratify low risk hematuria patients when compared to AUA guidelines. It provides the strongest clinical utility evidence yet for inclusion of Cxbladder products in a future update to the hematuria guidelines.
The STRATA study will be presented on the podium by Dr Yair Lotan, Professor of Urology at UT Southwestern. The presentation is scheduled during a session covering advances in bladder cancer care on the morning of the first day of the conference (Friday May 3).
STRATA will also be published in the prestigious Journal of Urology on the same day and will be promoted as “practice changing research” by the AUA and the Journal of Urology in the lead up to, during, and after the event. A link to the paper is provided below (and will only become active at the commencement of the podium presentation at 10:40am Friday May 3 CDT). A selection of published comments by key reviewers of the paper will also be made available following the event.
Referencing the clinical utility of the test, authors of the paper led by Dr Lotan, said in an abstract to the study that Cxbladder Triage “can help reduce the burden of unnecessary cystoscopies… resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact”.
The study showed clinicians in the test arm of the STRATA study, who could use information generated by a Cxbladder Triage test to help them determine the intensity of a patient workup, undertook 59% fewer cystoscopies than those clinicians in the control arm of the study who could not use the information from the Cxbladder test.
With the STRATA podium presentation providing a focal point for discussion throughout the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.
This year Pacific Edge will sponsor a tabletop session during the Urological Society for American Veterans (USAV) sub-meeting. This meeting will be attended by urologists working within Veterans Affairs (VA) facilities and is of particular importance as the company progresses its DRIVE and microDRIVE studies, both focused on VA patient cohorts.
Further detail on scheduled sessions at AUA 2024:
10:40am - 10:50 AM, Friday May 3 (CDT): Podium presentation - A Multicentre Prospective Randomized Trial Comparing Cxbladder Triage to Cystoscopy in Patients with Microhematuria.
10:00am - 2:30 PM Sunday May 5 (CDT): USAV Tabletop Session (Grant Hyatt, Texas Ballroom C).
Pacific Edge’s CEO, Dr. Peter Meintjes says: “The invitation to present the results of STRATA as practice changing research at AUA 2024, the world's most important meeting of urologists, reflects its first of a kind status and the potential for Cxbladder tests to redefine the standard of care. Going forward, patients presenting with microhematuria with a negative Cxbladder test, can be treated as AUA low risk, safely reducing the need for cystoscopy allowing urology teams to focus their time and clinical resources on those that need it the most, while reducing the burden of invasive testing on patients.
"STRATA provides the strongest case yet for AUA hematuria guidelines inclusion. Additionally, we will use the paper as the basis of a reconsideration request to Novitas2 regarding ‘Genetic Testing for Oncology’ local coverage determination (DL 39365)."
View the STRATA study published in the Journal of Urology. Please note that this link will become active at the commencement of the AUA podium presentation: 10:40am Friday May 3 (CDT).
1 PEB has not released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 Novitas, the Medicare Administrative Contractor with responsibility for Pacific Edge’s US laboratory, is currently reviewing Pacific Edge’s submissions on DL39365 and those of industry, the urological community and healthcare payers. Novitas must withdraw or finalize the draft determination by 26 July 2024.
Dear Shareholder,
A ground-breaking study demonstrating the clinical utility of Cxbladder is to be the centrepiece of Pacific Edge’s activities at the 2024 American Urological Association (AUA) Annual Meeting to be held May 3 – 6 in San Antonio, Texas.
The AUA Annual Meeting represents a unique opportunity for Pacific Edge to highlight the findings of the new STRATA study and drive the adoption of Cxbladder tests. The conference, now in its 119th year, is the largest and most influential event in the US and global urological calendar, and is expected to attract over 10,000 urologists, urologic oncologists, researchers, educators, advanced practice providers, and other healthcare professionals from across North America and around the world.
STRATA, the first ever randomized controlled trial of a urine biomarker for hematuria evaluation, demonstrates Cxbladder Triage can help clinicians to safely and more effectively risk-stratify low risk hematuria patients when compared to AUA guidelines. It provides the strongest clinical utility evidence yet for inclusion of Cxbladder products in a future update to the hematuria guidelines.
The STRATA study will be presented on the podium by Dr Yair Lotan, Professor of Urology at UT Southwestern. The presentation is scheduled during a session covering advances in bladder cancer care on the morning of the first day of the conference (Friday May 3).
STRATA will also be published in the prestigious Journal of Urology on the same day and will be promoted as “practice changing research” by the AUA and the Journal of Urology in the lead up to, during, and after the event. A link to the paper is provided below (and will only become active at the commencement of the podium presentation at 10:40am Friday May 3 CDT). A selection of published comments by key reviewers of the paper will also be made available following the event.
Referencing the clinical utility of the test, authors of the paper led by Dr Lotan, said in an abstract to the study that Cxbladder Triage “can help reduce the burden of unnecessary cystoscopies… resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact”.
The study showed clinicians in the test arm of the STRATA study, who could use information generated by a Cxbladder Triage test to help them determine the intensity of a patient workup, undertook 59% fewer cystoscopies than those clinicians in the control arm of the study who could not use the information from the Cxbladder test.
With the STRATA podium presentation providing a focal point for discussion throughout the event, Pacific Edge will be hosting a booth in the main hall alongside a range of other targeted activities through which the team will engage with customers and other attendees.
This year Pacific Edge will sponsor a tabletop session during the Urological Society for American Veterans (USAV) sub-meeting. This meeting will be attended by urologists working within Veterans Affairs (VA) facilities and is of particular importance as the company progresses its DRIVE and microDRIVE studies, both focused on VA patient cohorts.
Further detail on scheduled sessions at AUA 2024:
10:40am - 10:50 AM, Friday May 3 (CDT): Podium presentation - A Multicentre Prospective Randomized Trial Comparing Cxbladder Triage to Cystoscopy in Patients with Microhematuria.
10:00am - 2:30 PM Sunday May 5 (CDT): USAV Tabletop Session (Grant Hyatt, Texas Ballroom C).
Pacific Edge’s CEO, Dr. Peter Meintjes says: “The invitation to present the results of STRATA as practice changing research at AUA 2024, the world's most important meeting of urologists, reflects its first of a kind status and the potential for Cxbladder tests to redefine the standard of care. Going forward, patients presenting with microhematuria with a negative Cxbladder test, can be treated as AUA low risk, safely reducing the need for cystoscopy allowing urology teams to focus their time and clinical resources on those that need it the most, while reducing the burden of invasive testing on patients.
"STRATA provides the strongest case yet for AUA hematuria guidelines inclusion. Additionally, we will use the paper as the basis of a reconsideration request to Novitas2 regarding ‘Genetic Testing for Oncology’ local coverage determination (DL 39365)."
View the STRATA study published in the Journal of Urology. Please note that this link will become active at the commencement of the AUA podium presentation: 10:40am Friday May 3 (CDT).
Thats a hell of a coup. They are working their butts off.
This part is especially good.
"STRATA will also be published in the prestigious Journal of Urology on the same day and will be promoted as “practice changing research” by the AUA and the Journal of Urology in the lead up to, during, and after the event"
The AUA actively promoting it on PEB's behalf!
Discl Holding
Excellent work by PEB management. Hopefully the research will be the turn around required to keep Medicare coverage. Hopefully we will see a price adjustment to 20cents-$1 per share soon.
Disc-holding.
I also hold a 7 figure number of PEB shares (lower end of the 7 figure spectrum). What PEB needs is a opinion or a disclosure to the market of a opinion from a US lawyer on what the impact of the STARTA research will have on the Novitas decision that is in addition to the basic reconsideration information. Surely they have already sought the advice and based on legal guidance, moved forward with the research timetable as they have?
dunno if anyone read my post - i thought my email from PEB was released to the nzx
It was due to them mentioning the word "material", however they didn't consider it price sensitive. I suspect they then released to the exchange to cover their behind. Why sunnysleeper11 inferred it was removed is perhaps best explained by them.
Anyoldwho, the market has viewed the AUA news and Strata research favourably.
Thanks, I thought it was some secret email that indicated that there would be a favorable Novitas decision. Yes anywho, just a matter of waiting and seeing. I think alot of the investment houses in NZ have this graded as uninvestiable like Jarden and will be playing catch up if there is a favorable Novitas decision.
PEB has wind in its sails again this morning. :)
The AUA conference just happens to be kicking off.
Discl: Holding
Kick off is 10:40 on 3 May CDT, that's 17 hours behind NZT. The big deal is the STRATA study, the results of which are hidden until then and available on this link after that time.
Fingers crossed it's as pivotal to PEB as it's reported as being. Needs to be enough to overturn Novitas' desire not to fund CXB.
Disc: Also holding
All I need is the share price to increase by a multiple of 14 and I’m in the money.
The study and commentary is now up on tha AUA Journal link provided earlier by 850man. Still reading it.
https://www.auajournals.org/doi/10.1...e-8130cf1ff664
It appears you can read the study results, but to read the AUA editorial content you need to stump up with $39USD or be an AUA member.
It contains a lot of technical jargon that's well above my pay grade but it does read very positively.
Here's the final paragraph:
Oops - just noted that all the content is copyright and cannot be published anywhere without consent. Have to delete this - sorry.
You can read the report online though at:
https://www.auajournals.org/doi/10.1...e-8130cf1ff664
Is it enough to sway the bureaucrats at Novitas? We will just have to wait and see
Interesting info thank you for sharing.
I read a while ago that the FDA was unhappy with Novitas decision to say who and what they pay for as its was the FDA'a decision to make. Novitas just pay the bills..
Seems that PEB need to completar evisculate extensible services and it will be a game changer
It's a Creative Commons and can be shared so long as it's cited and not altered. The last paragraph is pretty clear:
"In conclusion, in this prospective multicenter randomized controlled trial, use of CxbT to inform the decision for cystoscopy in patients with LR hematuria resulted in a 59% reduction in cystoscopy. This demonstrated clinical utility of CxbT to safely reduce the burden of unnecessary cystoscopies in this population, theoretically resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact."
I think this is good news and hopefully it will have some sway on the Novitas decision. However, it appears to show results regarding clinical utility when the original concern for Novitas was the perceived bias in PEB's early clinical trials for efficacy. I'm certainly no expert, but are the results of the STRATA study enough for Novitas to put aside those original concerns? It would be great if that was the case, but who would know. Even if it is enough for Novitas to change their minds, I don't think that will happen before the July deadline. Given what we know of how slowly things work in the USA health system, a positive outcome based on the STRATA study may still be some time away.
My understanding is that efficacy is the ability to produce a desired result. The PEB result confirms that PEB's CxBladder can produce the desired result of safely identifying issues without the need for invasive surgery. The whole idea of doing a randomized control trial is to remove selection bias. I'm not sure whether the result is a king hit to secure Medicare
(as it was completed by PEB and not a independent research company), however it is peer reviewed and if it is supported by the urology community (I don't have access to the full research or info on this), I would be surprised if Novitas does not at least delay this current attempt to remove coverage, and give PEB another e.g. 12 months to get more research completed.
DYOR - Disc - holding
PEB looking to kick on from last week. Where's it all end? :D
I am somewhat surprised by the market being underwhelmed about the STRATA study endorsement on CX Bladder and the presentation to the American Urologist conference. To date SP up 4.8% this morning, but this stock has always news driven. I know patience is a virtue but this stock was first listed in 2003:(
It is likely that none of the big broker firms will look at PEB until PEB releases further information on 21 May 2024. We will get bigger positive movements after 21 May 2024 or if Novitas confirm Medicare coverage.
So a negative result requires no Cystoscopy and a positive result does??????
Yes, to identify what type of cancer, where it is and to what extent it has developed.
The benefit of CXBT in the diagnosis process is that many people who have symptoms that might be bladder cancer (e.g. micro hematuria) are reluctant to have a cystoscopy as it's an unpleasant procedure and frequently negative for cancer. Accordingly some positive cases are not detected early when treatment would be more successful. CXBT with it 99% NPV gives a patient peace of mind that their symptoms are not bladder cancer.
Here's to hoping that we get some strong comments or addtional information from PEB next Tuesday about the Novitas LCD.
CASH BURN SLOWS Coverage Catalysts in Focus
Another big loss taking Accumulated Losses to $246m …that’s a big number
One day things might be positive
Good luck to PEB getting the approvals they are after
http://nzx-prod-s7fsd7f98s.s3-websit...369/418809.pdf
This bit is encouraging
"End of period cash and cash equivalents of $50.3 million down from $62.2 million in
September 2023; a runway expected to be sufficient to support the company through to
regaining coverage in the event of a Medicare non-coverage determination."
Discl: holding
Alot of promising and indicative words used in the presentation re guideline inclusion. Good to see that Novitas has been provided with a copy of the Strata Cxbladder research. I'm not sure how Novitas can say no to PEB, they could surely come up with something but reading between the lines, PEB are showing alot of confidence that they will get there eventually, it doesn't make sense to pull the rug if PEB will get their eventually...
For Bars Review of the result
NEUTRAL
Pacific Edge's (PEB) FY24 result had no material surprises. Net cash of ~NZ$50m was slightly ahead of our expectations. The continued improvement in revenue per billable test (helped by a solid Kaiser contribution) was a small positive which offset slightly higher opex. We retain our NEUTRAL rating given the LCD outcome is binary and therefore high-risk, lab throughput is subdued, and under any scenario the risk of an equity raise within the next two years is elevated.
What's changed?
Earnings: FY25/FY26/FY27 EBITDA +NZ$0.7m/+NZ$3.0m/+NZ$1.6m with lower revenue offset by lower costs.
Target price: Increased to NZ$0.12 from NZ$0.11 given the modest earnings upgrades.
Pricing growth a positive in 2H24
A positive surprise was the continued strength in revenue per billable test, up +18% in 2H24 versus 2H23 and +6% sequentially. The two drivers are: (1) improved Kaiser performance — we estimate FY24 Kaiser revenue more than doubled versus FY23 to ~NZ$3.5m, and (2) an increase in proportion of tests paid for outside of CMS and Kaiser. At FY24 we estimate PEB's Southern California Kaiser population penetration is 0.05% (Southern California is ~37% of Kaiser's population) versus NZ at 0.08%. PEB's commentary suggested all 15 Kaiser Southern California sites volumes are increasing steadily, albeit it was conservative on the roll-out speed into other jurisdictions near term. Northern California is the likely next step, where its share of Kaiser's population is only modestly below Southern California. We had been sceptical of the patient pay strategy but early signs are positive, and we take comfort that the pricing uptick provides some insulation against the possible loss of CMS revenue (CMS was ~NZ$17m of revenue in FY24).
Solid opex control in 2H24
2H24 opex declined -NZ$4.8m sequentially to NZ$27.0m, with sales & marketing declining -NZ$3.0m, and G&A -NZ$2.4m. While this was less than we expected, PEB continues to accelerate the clinical research development which is the right strategy. For the time being, we see the 2H24 opex run rate as an appropriate base, but note PEB has levers to pull should the LCD decision require it.
Asymmetric upsides in the event of a favourable LCD outcome, but the uncertainty is very high
There were no new updates on the LCD decision which is due before 26 July 2024. PEB currently trades on ~1x EV/12 month forward sales. On a EV/sales multiple basis broadly consistent with biotech peers (5–6x), should the LCD decision be favourable, we derive a ~NZ25-30cps price. More comparable genomic peers, which have meaningfully lower revenue growth trade on ~3.2x EV/sales. Our discounted cash flow valuation scenario that assumes CMS coverage continues is NZ$0.24. We acknowledge PEB was trading between NZ$0.40 and NZ$0.50 prior to the recent unfavourable decision, but given the net cash deterioration and soft lab throughput trends, the share price may not recover to these levels (at least in the near term).
Earnings changes
We make minor earnings changes across our forecast horizon. We again downgrade our revenue expectations with lower CMS and ‘other US’ volumes slightly offset by higher Kaiser volumes and stronger pricing (combination of stronger Kaiser volumes and a higher share of US volumes, ex CMS and Kaiser paid for).
Our presented forecasts use our scenario that CMS coverage remains.
Our target price increases to NZ$0.12 (from NZ$0.11) reflecting the modest earnings upgrades. Our target price methodology is a probability weighted DCF scenario of: (1) no change to CMS coverage (PEB continues to be covered), (2) coverage resumes in FY27, and (3) coverage resumes in FY29. We acknowledge a tail risk that coverage isn't achieved at all, but we see this as very unlikely. Our valuation scenario that assumes CMS coverage continues is NZ$0.24.
It is interesting that For Bars set out that "We acknowledge a tail risk that coverage isn't achieved at all, but we see this as very unlikely". In a world where the business will get there or is very likely to get there to meet requirements, why would Novitas cut funding when there are cost savings provided by PEB :o
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.
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
"Urine Tests Could Be 'Enormous Step' in Diagnosing Cancer"
https://www.medscape.com/viewarticle...&impID=6539588
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.)
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.
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
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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)
Around 7 weeks until we have certainty on Medicare coverage unless a decision is made beforehand.
Strata research headlining Urology Times. Around 5 weeks left re Medicare decision.