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Re: Anshu2 post# 417182

Monday, 05/29/2023 2:49:29 PM

Monday, May 29, 2023 2:49:29 PM

Post# of 469361
The definition of efficacy is the same in AA and in regular approval. What is different is in AA the biomarker is thought to be predictive of efficacy.

With AA efficacy still has to be demonstrated in an additional trial that meets the standard definition of efficacy.

A subtle but important difference.

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