PEB - Pacific Edge Ltd

[nztx]

I reckon the ANZ funds...They have been gobbling them up lately

Think you might be right .. averaging down or a bargain near or under NTA ?

[Greekwatchdog]

Think you might be right .. averaging down or a bargain near or under NTA ?

Probably averaging down, given what they have paid. This is just waiting on Novitas to make a decision. If its positive it goes North, Negative who knows..Can't go much lower I guess.

[Greekwatchdog]

ANZ still gobbling them up https://www.nzx.com/announcements/423550

[nztx]

ANZ still gobbling them up https://www.nzx.com/announcements/423550

Who do PEB bank with ?

[etrader]

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

[Roskat]

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.

[winner69]

Wow ....what does it say and mean

[Greekwatchdog]

Wow ....what does it say and mean

Well I am scratching my head asking the same question W69. My interpretation is that Novitas has no right to do what its doing because its the FDA's job.

If I am wrong, someone with more medical knowledge please say something. Thanks in advance GWD

[carrom74]

Quarterly update is due anytime. I am expecting it next week.

[Greekwatchdog]

Quarterly update is due anytime. I am expecting it next week.

Agree with you on that.