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Re: Joseph_K post# 446905

Tuesday, 01/09/2024 8:08:10 PM

Tuesday, January 09, 2024 8:08:10 PM

Post# of 462260
I think the biggest problem with P2b/P3 is not the filed ADL endpoint. The biggest problem is the lack of dosage-arm data, which is highly likely to have a terrible p-value if any at all. FDA can't possibly approve a drug without a dosage recommendation -- and a dosage recommendation can only come from dosage-level data.
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