Replies to post #322247 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Gator328

I've been critical of Dr. Missling in the past, but I do applaud his decision to focus on an immediate, unmet need to create revenue -- Rett is significantly more likely to be approved quickly than Alzheimer's and I think the plan all along has been to use Rett to get the priority review voucher, which will then be used to speed up the FDA decision for Alzheimer's assuming the P3 readout hits all the endpoints. That is probably worth more than the $100 million or so he'd fetch selling it on the open market. With Biogen's drug having its own set of safety and efficacy issues, the opportunity to strike has never been better for Anavex.

I used to be primarily concerned that A273 won't have good P3 results. It's still possible, but my concern now is whether a competitor is able to sway the FDA into accelerated approval. If the Biogen approval showed us anything, being first is better than being better. Dr. Missling hopefully knows this and Rett approval will indirectly provide a catapult for Alzheimer's that puts us over the finishing line first.

We'll see...

Agree w/your points and would also add that Dr.M. (IMO) is going for the Verification & Validation of the AVXL MOA claims. Restoration and Regeneration evidence is/will be WW breakthrough stuff. RSD, PDD and AD trials are the method of proof (CNS COMPILED evidence from 3 trials). Proof by suitable WW review considering this level all positive will open the WW eyes on CNS the disease spectrum and the AVXL CNS cellular Homeostasis claims are proven. IMO, he is doing multiple trials for this reason. IMO, WS does not see what is REALLY going on w/AVXL yet.

I admit it is unclear right now what can be done to make such a claim credibly (short of actually performing-completing the trials as planned). At some point the combined AVXL trial plans will be linked, Stand by.

It's all about validating the MOA, one CNS indication trial at a time, then a flashover happens.