Anavex Life Sciences Corp (AVXL)

[JB3729]

It's going to be interesting to see how long it takes before major drug companies, with major bucks spent on AD (Lilly, Pfizer, Biogen, etc.), make their move for Anavex.

Eli Lilly ($LLY) didn't just surprise investors with its sudden about-face last week on its long-running Phase III program for the Alzheimer's drug solanezumab. Some investigators with years of experience in the field have been puzzling out the move to downgrade function from a co-primary to a secondary endpoint, even though daily function and improved cognition remain a required combined feature for any pivotal trial design approved by regulators on both sides of the Atlantic.

The bottom line is that Lilly clearly thinks its drug--which failed two earlier late-stage studies only to see Lilly double down, convinced that a second look at the data pointed to a clear clinical pathway that would lead it to one of the Holy Grails of drug research--is going to fail at significantly improving function. Facing the prospect of a repeat, high-wire flop for another one of its pricey home run swings, executives decided to retreat to cognition, hoping that the data would be good enough to argue the issue with regulators, who will be feeling the heat from patients and advocates with no truly effective therapies to turn to.
http://www.fiercebiotech.com/story/can-eli-lillys-regulatory-gambit-salvage-its-alzheimers-drug/2016-03-20

In addition to "the emergence of such strong cognitive signals", A2-73 recorded this on function -

In the interim analysis of the first 14 patients at week 12, the PART B portion of the study demonstrated a positive trend towards improvement over 12 weeks of ANAVEX 2-73 treatment on the secondary functional outcome measure, the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) by +3.21 points.
http://www.anavex.com/?news=anavex-announces-positive-primary-and-secondary-endpoints-were-achieved-in-a-phase-2a-clinical-trial-of-anavex-2-73-in-alzheimers-disease%e2%80%8e