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Re: Doc328 post# 391539

Sunday, 12/11/2022 4:16:59 PM

Sunday, December 11, 2022 4:16:59 PM

Post# of 519040
what does the pre-specified subgroup analysis do for p3 trials? Does it enable a drug approval for that subgroup (e.g. WT with drug label) in the event the whole group not meeting primary endpoints? Or only the subgroup analysis only serves as basis for the next p3 trial?
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