People seem to always lose track of the big picture and then focus on the minutia of the trial and then drawing false conclusions based on such "analysis."
Bottom line - the phase 2a has always been a SAFETY study - not designed to demonstrate efficacy - though, as a secondary endpoint, potential for significant efficacy has CLEARLY been demonstrated especially with the small cohort of super responders.
What does this all mean?
It means that now we know that Anavex 2-73, when given to patients with mild; mild-moderate AD (the earlier the course the better), at high concentration levels in the blood is more likely to contribute to stabilization of mental status as evidenced on MMSE and ACDS-ADL scores. In addition, we have other objective biomarkers that have been measured in these responders.
All of the data gathered now means that we can confidently proceed with an EFFICACY phase 2/3 trial with much more specific inclusion criteria using the data we have from the superresponders in order to ensure that we effectively design a likely to succeed pivotal trial.
All of this suggests that, in the long run, we are in perfect condition to continue and eventually succeed in order to get through phase 2/3 and eventually FDA approval.
There was NOTHING negative in the longterm for the CTAD results that came out.
I was not expecting a huge share price increase today - in fact, I expect a drop.
Most people here do not know what they own and seem to be scared, very easily, out of their shares. I know what I own because I understand the theory and the science. That, is what counts to me the most.
Come 2020, I will be in very good shape (with all of my shares held in the longterm so once I sell, I only have to worry about longterm capital gains).
