In general a company has to have a P3 trial in hand to go to the FDA. Anavex is just finishing P3, or what the company expects to be classified as P3, trials.
Missling has said that he is aggressively pursuing AA for AD. The Rett pediatric trial is getting close to completion which is also expected to be a P3 trial.
Got to have the right trials in hand to go to the FDA. Remember the Anavex MOA is untried and way out of the medical mainstream thinking. Missling has to have solid data in hand.