ha..you have resurrected our old OEM thread...we started popping everything in the General Discussion thread, since many months passed with no OEM developments...yes, might need to add more info this one, considering all the OEM negotiations shown in the presso today.
In regards to the FebriDx FDA 510(k) app, I don't believe it has been submitted yet - hence the "CY21" there that its planned - which we know already.
If you recall earlier (Sept or Oct'20?), I had posted that FebriDx data page @ ClinicalTrials.gov site was blocked out, per FDA guidelines for an active clinical trial that was in progress for FDA submission. We know that FebriDx US trials were delayed due to Covid19 focus/lack of patients volunteering for it etc...but then it restarted, with the aim to finish Dec-Jan'21..and then FDA submission.
FYI for those that don't know, US FDA 501(k) is an often used process by US medical companies - to grandfather in new tests/devices that are "..marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device"..in other words company A has a test that has FDA approval ...then company Y can come along and say "my test is improvement OR v different but same goals OR similar" to company A's approved test...and get their new test approved more quickly...
AT1 Price at posting:
24.5¢ Sentiment: Buy Disclosure: Held
