Replies to post #452881 on Anavex Life Sciences Corp (AVXL)

[skitahoe]

Do you know how well our data compares with the data being cited here:

https://finance.yahoo.com/news/minerva-neurosciences-receives-complete-response-130000303.html

They got the dreaded CRL.

For a Phase 2 to gain approval it must have been done with pivotal quality material, do you know that to be the case. If it is, it could be referred to as a Registrational Phase 2.

Personally I'd like to see the FDA do more conditional approvals, either requiring a confirming trial, or for all receiving the drug reporting results in a Phase 4, perhaps even both until they're satisfied with a benefit. All to often tiny companies can't afford the further testing the FDA requires and good drugs are either abandoned, or sold to a BP dirt cheaply.

Gary

[Steady_T]

It is a P2 trial that among other things is attempting to establish the appropriate dose. It has 5 arms to it with a total of 40 subjects, there won't be nearly enough subjects in each arm to justify approval or allow reasonable statistics. It has approximately 39 Primary outcomes and 8 secondary outcomes.

This is a P2 trial that will provide the data to design a P3 trial.