Biogen Inc (BIIB)

[DewDiligence]

Hi, JL. I do agree that the FDA’s accelerated approval of Aduhelm based on the premise that clearing amyloid is “reasonably likely” to predict a clinical benefit was a serious overstep.

It’s now going to be much harder to conduct illuminating clinical trials of other AD drug candidates. Few patients will want to enroll in a trial with a placebo arm, and a head-to-head non-inferiority study of a new agent versus Aduhelm wouldn’t really demonstrate anything even if the trial met its endpoints.