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Re: Doc logic post# 65736

Tuesday, 06/28/2016 5:59:11 PM

Tuesday, June 28, 2016 5:59:11 PM

Post# of 701236
Doc logic, in what context are you talking about the pseudo sub trial being supportive?

If you mean as support for a single pivitol trial, I agree. It could well serve as such and might even be the reason it was designed in as it was (to terminate concurrent with the main).

But for serving as the confirmatory trial for an AA, I fail to see how that is possible. If the data is good enough, it could help in getting a full approval. But how can the FDA issue a conditional approval (AA) that needs to be confirmed by a trial that would already be over? Also, the N in that trial is small for OS. Remember that the FDA shook of CLDX for N=89(?) that was stat sig on both PFS and OS for that very reason.
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