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Re: 12x post# 462199

Sunday, 06/23/2024 12:19:27 PM

Sunday, June 23, 2024 12:19:27 PM

Post# of 471396
Your question about an exact example misses the point. What matters is if an NDA meets FDA criteria for approval at the time of the Agency's decision, and not whether there was a change in endpoint usage after the original trial design. You are concerning yourself with style points rather than the anticipated regulatory outcome.
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