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exwannabe

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exwannabe

Re: CaptainObvious post# 690361

Friday, 05/10/2024 1:46:12 PM

Friday, May 10, 2024 1:46:12 PM

Post# of 693857
Sticking to the general question/issue. ...

Look at the approval history of Yervoy.

BMY grew a P1 into a 1000+ patient pivotal trial, but with some quirks that could cause issues. So they started a concurrent trial with a more normal design. When they tried for approval on the expanded P1, the FDA peeked into the P3 (still blinded) for supportive data.
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