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Re: Joseph_K post# 448886

Tuesday, 01/23/2024 2:45:04 PM

Tuesday, January 23, 2024 2:45:04 PM

Post# of 462196
I do give credence to Sept PR of p<0.025. But there are two big problems: (1) Where is the dose-level data and efficacy? (2) Why the 1.5 years delay in getting FDA in line for an NDA?

For these two reasons, I consider the “true” efficacy results to be questionable.

Regarding what I would recommend— if AVXL is approved. If AVXL is approved, I’d think that I’d have access to much more detailed and complete trial data (which we don’t now) — and the answer would really depend on analysis of that data. Determining before that is shooting in the dark.
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