So once and for all, is this crappy drug getting approved?

Ok responding to your own post is lamer than lame. Poor bastard.

 

NO!

"This all indicates that the FDA will take a tougher stance on drug approvals under the Biden administration, Porges wrote. There are also signs that the lack of a permanent FDA commissioner is affecting one of the most highly watched drugs of the year: Biogen's Alzheimer's disease treatment aducanumab."

 

This on again/off again saga is destined to continue thru most if not all of 2021.

 

Saga will definitely end by June 7th as the FDA can't extend it out any further. So with that said, what others have posted was correct:
a. They are currently not working on the package insert - what does that tell you? This takes a long time
b. Interim FDA Commissioner Janet Woodcock is pro industry but when she went against advisory board for other things like Narcotics, it bit her in the ass and she is losing credibility
c. Does not help data isn't strong and there are not two positive phase 3 trials
d. Does not help that situations like J&J's covid vaccine being pulled for side effects as FDA needs to be more cautious about approving things
e. Advisory board's stance and JAMA publication
f. Public Citizen crying foul
g. Too many unknowns about safety and complexity of REMs

 

h. The ICER report is also getting ready to drop. That will be a kill shot.

 

iCER won’t make call on approval; only whether the drug is priced at an appropriate cost:benefit level. Has much more of an impact on potential formulary positioning.

 

A+ post

 

All unfortunately valid points. No one thinks this is getting approved but did hear we will get a decent severance if it doesn't happen. So at least Biogen takes care of their people. I do hope some of us get to move internally to other opportunities.

 

“Biogen takes care of their people” by offering 2 weeks severance for every year of employment- that is what they have always done, and will do here. If you moved over from another division, that counts. If new, you get your 2 weeks

 

Honestly, I’m much more focused on the 8+ months of free salary that I will have drawn during all of this. Severance is house money and only relevant if someone was foolish enough to sit on their rear and not develop a plan B.