I still think M is not sure about efficacy of A2-73 - as such he is going into Analysis-paralysis mode and delaying AD trial start as much as possible.
There is no much data you can generate from 32 or 25 patients - he already used some 80 attributes in Ariana - how many combinations one can analyze? There were 32 patients out of which 25 finished.
I would hope that they not ONLY use patients who have a favorable bio makeup for best results, but use others as well. It would provide much more information.
I am sure the FDA application/protocol could not have been done months ago. This is the process. People just have to deal with it or start their own CNS focused biotech company.
Not everyone here thinks 2-73 is some "wonder" or "miracle" drug. We have posters here with more tempered expectations. I suspect the truth is somewhere in between the most enthusiastic and most pessimistic. All we need to beat is SOC, which isn't a high-bar to clear. For Retts, there is NOTHING. For Alzheimer's, if we can prove stabilization (not reversal) for 6+ months in 25% of trial participants, 2-73 gets approved and is the new SOC. I believe what Missling/Anavex is doing might even bring us above 50% stabilization of patients because of the pain-staking inclusion/exclusion data by using DNA/Biomarkers to determine who will best respond to 2-73. Now, lets say there is a reversal in a small population of patients...now we are talking a whole different ball-game. But reversal IS NOT necessary to gain FDA approval.