Replies to post #96298 on Anavex Life Sciences Corp (AVXL)

[F1ash]

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Supposedly, they have three trials about to start up but only 20m; and retail seems to be okay with this?
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Phase 2 trials can be run relatively cheaply. I know of a current ~200 patient Phase 2b that is budgeted at around 6-7 million dollars. So that's doable.

The concern for high expense usually comes in the Phase 3 portions.

I've seen the number 300 thrown around for an estimated Phase 2/3 trial size for A2-73. From things I've looked at, that might be big enough to satisfy investors, but I think the FDA might not be satisfied with that data.

I'm not sure that everyone understands the concept that a drug company can run a trial that is authorized by the FDA, but (and this is the important part) that does not mean the FDA will be satisfied enough with the data to approve the NDA. If a company wants to be sure that the FDA will approve the data as satisfactory they have to seek a SPA agreement prior to starting the phase 3.

I looked at a historical Alz trial that required 1700 people in the Phase 3 and their Phase 2 data was better powered and blinded. It would be nice to hear Anavex comment that they had submitted a SPA. That's the only way to be sure that the FDA won't come back and require another phase 3 for additional data.