Agreed Nidan. The FDA has apparently placed a fork in the road leading to CNS drug approval.
Big Pharma (except perhaps Biogen) have seemingly taken the same disappointing turn towards withdrawal, whereas Anavex recently announced plans to take the fork towards (pioneering) precision medicine CNS trials by utilizing in depth pk/pd data and Illumina’s genomic sequencing analysis and biomarker analysis (paralleling successes in the oncology space).
Quite a dichotomy.
Add to that, in Fall 2017 the Company and Ariana outlined why they BELIEVE that the cognitive IMPROVEMENTS & STABILIZATIONS are dose dependent (or blood concentration dependent) rather than the alternative (random responses possibly unrelated to 2-73 efficacy), see pk/pd & ctad presentations.
As you said, none of this guarantees success for Anavex, however I’d conjecture that it certainly helps to POSSIBLY explain the Company’s/CEO’s confidence (in recent conference calls and appearance at the Noble panel), and/or the Forms 4 ceo stock purchases, and/or the BOD large additional stock option awards in December 2017. Just my opinion of course.
GLTAL