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Re: Laurent Maldague post# 417708

Sunday, 11/05/2023 7:52:24 PM

Sunday, November 05, 2023 7:52:24 PM

Post# of 447337
Laurent, I have no idea what clinical research would look like post BRAVE. Are you familiar with the most recent FDA guidelines for an Alzheimer's disease drug approval? Preclinical has the lowest bar for an indication. Positive effect on biomarkers. It is unclear if damage done during disease progression is reversible. This might be why FDA stratified the evidentiary requirements. How would you construct a large long term study on preclinical patients?
Sleven,
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