Replies to post #235492 on Biotech Values

[IanFromSI]

While I agree with "non-binding" as being an important word, if we were to go for the most important sentence for the FDA to use it would be:

"Finally, the Advisory Committee voted 0 yes, 10 no and 1 uncertain on the question, “In light of the understanding provided by the exploratory analyses of Study 301 and Study 302, along with the results of Study 103 and evidence of a pharmacodynamic effect on Alzheimer’s disease pathophysiology, it is reasonable to consider Study 302 as primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease?”"

Not a single adcom member thinks there's any value whatsoever to patients from the use of ADU. Surely the FDA could not, in good conscience, totally ignore the advice of their own advisors.

[ronpopeil]

I can’t imagine BIIB not getting a CRL