Anavex Life Sciences Corp (AVXL)

[Anshu2]

Unfortunately, that’s not how FDA decides on approval. It follows the law on what is required for approval — even if it sometimes misjudges the evidence.

For approval, you need “substantial evidence” of efficacy — which is defined as “two well-controlled and one very compelling clinical trial” demonstrating statistically significant efficacy of clinical endpoint. Of course, the safety should be “tolerable”.

For AA, same as above — except replace the last phrase “clinical endpoint” with “surrogate market or intermediate endpoint which reasonably likely predicts the clinical endpoint”.

Does P2/3 satisfy the above? I certainly don’t see any surrogate marker or intermediate endpoint, yet. So, AA is out.
Regarding full approval — the OR endpoints aren’t going to cut it IMO. The delta-endpoints may — but AVXL is hiding many aspects of them, so they are likely insufficient.