Replies to post #96460 on Anavex Life Sciences Corp (AVXL)

[amstocks82]

"In other words; the FDA participates in the trial design. If results are good, the FDA will be happy even with 300 patients. "

I did not think that "guidance" meant it was the final agreement for the trial design of the approval for the initial design concept.

Given A2-73 has gotten "orphan drug" assignment by the FDA for some uses, the FDA waives the fees they would otherwise charge to work with the company on the design and are required to provide help in the design of the trial if requested.

Anavex's Phase 2A/2B trial provided more data than usual and seemed to be a very good design for that trial. I wondered if the FDA helped them on that also.