IMO, this is the best opportunity the FDA have to break new (precision Medicine) trials ground. FDA have painted themselves into a corner from which there is no attractive exit with existing trials methods. After 30+ years of massive AD spending and efforts they have nothing to show. That is more than just a little bit of a process failure, this is a leadership failure. IMO, that is why Dr.M. has done it his way (off shore-PM trial methods-better-more data.).
So, a strong AVXL trial right now could present a double hit for FDA leadership. Not only did they continue to beat a dead medical trial but they were also on the wrong trail.
They will require a new process-trial (if BIIB wants to play). If not, BUH-Bye Amyloid Plaque thesis. Current trial method is an obvious-embarrassing failure, put the entire (incomplete-mess) thing out of it's misery.
Start (BIIB) over with PM trial, if it works we'll look at it. Stop the games. IMO, this is the best way for FDA to save face and add value.
PM is the obvious best path.
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