RE: Likely Up tomorrow after FDA approval of BIIB8 Jun 2021 10:59
What is a de novo?
• An application sent by the medical device sponsor to FDA
If granted:
Establishes new “device type” along with classification,
regulation, necessary controls and product code
Device is eligible to serve as a predicate (First of its type) for new medical
devices (applying thereafter), where appropriate.
I'd be surprised if we jump to he same extent as Biogen due to their subject matter (Alzheimers) and the fact that they are not on AIM. Also, our platform - amazing as it is - is more complex to understand where retail investors are concerned. What many of them will wrongly have seen is Biogen providing "a cure for Alzheimers", and followed the herd.