Anavex Life Sciences Corp (AVXL)

[Steady_T]

Today's data release explains why TGD thought that approval for Aud** would be good for Anavex.

The FDA approval legitimizes the use of biomarkers as standalone criteria for drug approval. Now that that Anavex has shown the biomarker improvement at more than the minimum stat significance, the FDA is in a position for accelerated approval of 2-73 for Rett adults. The biomarker improvement along with the other end points improvements, and the safety factor make odds of approval for 2-73 look very good.

This does raise one question for me, will the FDA wait for the pediatric trial results before considering 2-73 and approve it for all Rett ages or will the FDA approve 2-73 in adults first and then consider pediatric usage.