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Re: BAR123 post# 417170

Monday, 05/29/2023 8:43:43 AM

Monday, May 29, 2023 8:43:43 AM

Post# of 517495
Blar, the operative word is "accelerated." Going for the full approval will take longer while AA approach is more focus on a limited number of measurements, i.e., biomarkers. The scope of the AA filing might be XX% less than the full approval filing plus less time to file. Anavex believes that it has a good chance for AA based on the fda's decisions on B&E and Lilly. Those precedents might make it easier for the fda to give AA versus a full approval on a new MOA by an unheard of tiny company (regardless of the results).

This might be too simple, but it makes sense to follow the path that has already been cleared.
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