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Re: mrplmer post# 369540

Monday, 08/08/2022 10:03:52 AM

Monday, August 08, 2022 10:03:52 AM

Post# of 462184
The way I understand it, submitting Avatar alone was a bit of a risk -- even though the data was good, there was so much uncertainty based on the "goal posts" arguments made by Feuerstein and others. Positive Excellence data submitted alongside Avatar provides a more robust NDA for the FDA to review.

With the FDA you only get one crack at approval most of the time, so I don't mind the delays if they will help improve Anavex's odds of approval down the line.
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