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Gator328

08/08/22 10:03 AM

#369543 RE: mrplmer #369540

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.