Wednesday, July 12, 2017 10:58:25 AM
IMO, the shift in emphasis for the FDA trials away from massively expensive numbers based trails which go on for years. (note, such trials by default have favored BP).
Many will be unable to let go of the current CNS trials model for one that is based on a smaller/faster/deeper structure. Looking for one where trials success is based on all pts quality of life and not some minimal number of (acceptable)adverse events, such as those endured by AD patients for the past decades. There is no such thing as a "little" brain swelling. If I were BIIB I would be at a crossroads with this next step. What if they are conflicted by current investments and commits to the old school trials?
IMO, BIIB is fine as long as they can walk and chew gum. You are correct though we need their constructive buy in.
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