Anavex Life Sciences Corp (AVXL)

[Steady_T]

Having read those links and seeing that they have nothing to do with the discussion at hand, the distinction between P4 and P3 in the case of the Anavex AD NDA is pretty obvious.

With a P4 trial and AA the drug is on the market and generating revenues.

The P3 trial you have repeatedly claimed was going to be required would be a large trial and delay application for NDA until the trial is completed. That would be another 1 to 2 years.

Now with Missling's stated pursuit of an AA starting a P3 trial enhances the chances of AA and does not delay the revenue stream.

What is not clear is whether the FDA will accept the present P2/3 trial as sufficient to satisfy the efficacy requirement for full approval. If that is the case then there would be no need for the currently planned P3. The usual post approval P4 trial would be sufficient. If the FDA agrees with you that an additional larger P3 is required then the trail will be designed and underway when AA is granted.

Those links you provided suggest that the FDA is generally unhappy with the way companies have been slow about doing the required P4 trials when AA is granted. We have seen articles about this before. In fact I recall one article showing that a fair percentage of the required P4 trials had not been completed after 10years. So the FDA is now tightening up on the P4 timeline and wants to see concrete actions on doing a P4.