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Re: Joseph_K post# 417162

Sunday, 05/28/2023 11:47:49 PM

Sunday, May 28, 2023 11:47:49 PM

Post# of 463925
I had explained this earlier.

If AVXL gets AA based on some biomarker data in P2b/P3:

First assumption is that FDA will only give AA without any subgroup analysis, except for the dosage grouping. This assumption is extremely likely to be true.

With that assumption — a confirmation trial would need to show clinical benefit for the same population as in the P2b/P3 (else it wouldn’t be confirming the basis of AA).

That’s why.
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