and zero repercussion in the aduhelm fiasco...whic
Post# of 151350
Quote:
I don't think you can have the showmanship and play by the FDA rules at the same time, unless you are Pfizer or the likes. We found that out. The showmanship and circumventing the FDA landed us a hold for "safety" reasons and it was probably Gilead prodding the FDA that got us the hold. When there are regulations and billions of dollars at stake, and you put them in the same room, what possibly could go wrong? Aduhelm, he says clearing his throat!
So our approach right now is totally the right one, sneak in the backdoor before anyone notices and then you are in the house. It only takes one person and I'll bet Dr. JL knows who that is right now. Working that out with so many indications might be the hard part.

