I was reading an article about the upcoming FDA decision on Aducanumab that I thought on aspect was worth sharing.
The CNS Drug advisory committee has only reviewed 5 drugs in the last 5 years (including Aducanumab). Of the 4 where we know the result 3 were in line with the committees views and one was against. The one that went against the committee was for Eteplirsen and the question was over efficacy. The committee was overwhellingly against efficacy being shown but the drug was still approved.
However, what I think is interesting to watch is how long the FDA decisions took. Where the FDA decision was in line with the committee the approvals came very quickly in less than 2 months. I reckon it is worth keeping an eye on this, I suspect if we slip in to the new year without a CRL it starts to improve the odds of an approval.
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