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). ##