Anavex Life Sciences Corp (AVXL)

[Steady_T]

None of that is inconsistent.

We know that Anavex has fast track and other designations from the FDA that provide for "frequent meetings with the FDA". So having the FDA look at the progress on the various trials and requesting the trial be made a P3 is not out of the question. I can see the conversations going like "We have looked at all the data that you have collected on 2-73 and the initial Rett trial, the fact that the DMSB found no issues, so we think you should go ahead and make this a P3 trial."

Anavex would then need to go to the countries that are actually supervising the trials and request approval to make those changes. After all it is those countries whos rules the trials are being run under.

The FDA didn't need to be "proactively reach out to Anavex". Anavex is having frequent meetings with the FDA.