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Re: Doc328 post# 501731

Tuesday, 09/30/2025 9:24:03 AM

Tuesday, September 30, 2025 9:24:03 AM

Post# of 519112
Re: 5 percent and the need for another Phase 3

I have examined all of the MAA disapproval recommendations over the past twelve months and found several small, single trial examples. None of those disapprovals, however, cited the lack of a second trial in explaining the reasons for the negative opinion. I don't know where you are getting this requirement from.
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