Replies to post #454085 on Anavex Life Sciences Corp (AVXL)

[skitahoe]

I agree with you, I believe that the company can speak with the FDA about it and with positive adult results, benefits shown in minors, in spite of not meeting targets, the FDA could say to submit an NDA and let us consider it some more. If they do an approval isn't assured, but it could happen, perhaps with conditions that they either run a better designed confirming trial, or that all applications are reported in a Phase 4 for the immediate future.

I believe that the company can also show results that were sustained beyond the trial, and that in time placebo patients failed to show continued improvements, but the people judging the placebo patients believed they were seeing improvement. Worst case the FDA tells them they must run additional trials before an approval is possible.

Going for approval in AD may be the faster route to approval. Once you have an approval, off label use would be possible in RETT's and other diseases, but Drs. and patients would have to fight to get insurance coverage.

Gary