Mar. 7 at 2:22 PM
$BCLI Prasad was generally known to argue for strong randomized trial evidence and lack an innovative mindset open to adaptive frameworks exploring the totality of evidence. He often criticized approvals based on, surrogate endpoints, weak statistical significance, and subgroup analyses after a failed trial. This is also a big reason why he has been criticized in the rare disease community where regulatory flexibility is warranted. While he wanted degrulation and faster approvals, this didn’t change his stance on evidence confirmation. The citizens petition needs someone who is patient-access oriented, open to and endorses flexible evidence interpretation in totality and conditional approvals. This development of his departure is bullish for brainstorm. Let’s hope they get someone in there that not only endorses faster approvals, but whose evidence confirmation expands to include the totality of evidence that puts patients first.
