Anavex Life Sciences Corp (AVXL)

[seventhwave]

In the testing conducted in this adaptive trial so far, there is probably a pretty large dispersion in efficacy of A2-73 given the 6 super-responders on one hand and the 7 dropouts on another. The remaining population is probably spread in between. (This board hasn't quite addressed this likelihood squarely.)

It is the reason why all Anavex presentations have shown averages and avoided individual responses (eg. in time series data.) Fair enough thing to do by mgmt. as they can focus on subpopulations on which it can be statistically proven to be successful in advanced trials. Presenting mixed P1/2 data details would cause the market to take away benefit of doubt and chase Anavex out of business.

Hope a large part of the reason for mixed results is sub-optimal dosing and the curious upturn in data post 52 weeks is tantalizingly intriguing. If the protocol doesn't allow for dose escalation, as it isn't declared in clinical trial design then what is causing this inflection to the upside??? Is this new trend sustained??? Is it why Missling's playing cool?

Lastly this large dispersion (on limited n=32 sample) is likely the main reason why Anavex is taking every bit of time to release PK/PD data and trial design for P2/3. It is why they are using Ariana because if we had 32 super-responders (or even > ~16? or 20? for some of you) we would not need Ariana. Once PK/PD is out, there's no going back.

Some past AZ drugs like Prana's for example, probably did work to an extent but didn't have the efficacy enough to prove statistically significant in the trial that was approved by their mgmt. Missling & Co. knows it's not a slam dunk and trial design will make it or break it. Missling and his Scientific Advisory Board seem to have necessary savvy to make it a success.

Long AVXL - may the force be with you.