The conclusions from the really small P2a open label trial are based on an interesting amount of analysis paralysis. You are right that analysis likely doesn’t dependently explain what is going to trusts as selection characteristics of patients for PM trial.
Strong non linear relationships may be more linear when reviewed using a much bigger population, 21 versus about 450 subjects.
The idea is of course that more will be learned from doing the whole KEM analysis again this time with the larger and controlled trial datasets with even more factors to analyse.
The same was or is being done on the PDD data, except the conclusions we haven’t heard of yet as the expected peer reviewed paper from that trial is still expected…
Once all that data and analysis gets pulled together with OLE data analysis too, then Anavex should know with more confidence what characterises A2-73 responders.
That may then all be precise enough knowledge for a trial perhaps with a single DOSE TITRATION arm that seeks to get most of the correctly selected patients for enrollment up to their therapeutic concentration and respond as expected.
The focus is precisely to understand the patient characteristics of response to A2-73, dependable dose /concentration relationships should fall out of that analysis too.
Imo it will be a while before we know the results and next steps for A2-73 and AD/PDD PDD P3 trials and less likely imo of any early approval.
Rett and EXCELLENCE is next catalyst stop, not AD imo.
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