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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 discovery platform-ProMIS and Collective Coordinates-to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. Its product candidates are PMN310, PMN267, and PMN442. The PMN310 is a monoclonal antibody designed to treat AD by selectively targeting toxic, misfolded oligomers of amyloid-beta. PMN267 product candidate targeting ALS. PMN442 is a drug candidate being developed for MSA designed to selectively target and protect against pathogenic a-syn species.


NDAQ:PMN - Post by User

Post by Mole101on Jun 10, 2021 10:23pm
234 Views
Post# 33370351

Why is important to cross your I&T

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.


 

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