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Bullboard - Stock Discussion Forum ProMIS Neurosciences Inc PMN

ProMIS Neurosciences Inc. is a clinical-stage biotechnology company. It is focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). Its proprietary target discovery engine applies a thermodynamic, computational... see more

NDAQ:PMN - Post Discussion

ProMIS Neurosciences Inc > Why is important to cross your I&T
View:
Post by Mole101 on Jun 10, 2021 10:23pm

Why is important to cross your I&T

let's do that Serology test right ,  a misstep could be deadly..


FDA accuses company of distributing unapproved Covid test and using falsified data
T

he Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance.

The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States.

“Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA,” the agency wrote.

It’s unclear how many of the test kits were distributed or to whom, but Innova’s unapproved distribution and usage was widespread enough to catch the attention of regulators. The company had applied in August 2020 for an emergency use authorization (EUA) for its rapid antigen test, like hundreds of other Covid-19 test manufacturers who have earned market approval from the FDA. But the test had not been cleared for use in the U.S., though it is approved for use in the United Kingdom.

In its letter, the FDA also noted significant concerns with the data Innova is using both to try to get regulatory approval and to promote its tests. The agency said it found that on two of its test kits configurations, Innova included falsified data inflating the tests’ effectiveness.
The clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configuration devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices,” the FDA wrote.

Comment by retiredcop on Jun 10, 2021 11:17pm
Well said mole... very important for PMN .. we are a company that is possiby going to NASDQ.. the last thing we would need is a regulatory warning or sanction from HC or FDA  even if it is something our JV partner intiated on their own ... I always read that sign at my mechanis shop... if you want it done right it will cost more and it will take longer..if you want it cheaper it will be done ...more  
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