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Re: rayovac812 post# 432569

Monday, 09/25/2023 3:29:11 PM

Monday, September 25, 2023 3:29:11 PM

Post# of 466529
Thanks for some of the info. Two comments.

1. I doubt FDA would accept brain volume as a surrogate marker (I gave my readings in an earlier list). But it may.

2. Biggest issue I see is dosage arm data. Since CM hasn’t released it, I’m inclined to think that dose-level data is not statistically significant and/or has other issues. FDA will certainly not approve based on pooled data — that’s guaranteed.
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