i grow weary of pointing out the obvious..
the Anavex trial is OPEN. They HAVE the DATA, not just for 12 Weeks but for 26 weeks, interim 38, interim 52..heck they already have some beyond 52 week data probably..it is an OPEN TRIAL..when they do the Tests THEY HAVE THE DATA..put it in the computer..send it to FDA ..NOW FDA has the DATA.
The PK data is important BUT the PK data that was MOST IMPORTANT we already HAVE! There is ACTION at 5Mg, significant ACTION at 14 Mg and not a major diffrence in respnce between 30Mg and 50Mg. THAT IS PROBALY not going to change..right?
They have the DATA they need to Proclaim Breakthrough..RIGHT NOW..