It is odd that the ‘expected’ PDD peer review paper is still not out.
Perhaps one explanation could be that it addresses the dose level, titration, tolerability and non linear response issues in detail.
Those details are potentially well understood by now, but actions to manage titration, tolerability and responder selection wasn’t part of the P2b/3 AD trial protocol. Since we have seen an Anavex patent that addresses both titration schemes and drug composition of matter methods again not incorporated in current and recently completed trials.
So publishing that paper now would be too revealing of why the P2b/3 trial did not work out as well as it might have, but a confirmatory trial design taking everything learned into account likely would give more solid results for traditional approval.
Like you say and I think most of us expect, Rett is far more likely to achieve approval for A2-73 despite those trials not being optimally designed either.
With Rett approval all that can be revealed and the company can move on with new trial designs across the board including the long awaited ones on the back of an approval.
A risky strategy for managing market reactions, but delay and hope for Rett approval might be a calculated risk Anavex is taking.
Then with luck there is still some potential to also land AA for AD supported by biomarker data clearly characterising responders.
Hoping EXCELLENCE is the key to moving forward with clarity.
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