Anavex Life Sciences Corp (AVXL)

[nidan7500]

see our trial design and understand we are handpicking our participants, they will realize our chances for success are extremely high

Hand Picking and precise science are IMO linked and fundamental to what DR. M. has been saying all along. He wants to optimize trial performance to demonstrate A2-73 efficacy. IMO, he is doing this so that we actually learn something from the very expensive, time consuming and expensive, risky trials. BTW, while we are being as honest as possible with patients. I call it being smart and honest about what you are doing and expect to prove. Alternative (imprecise science) methods of the past resulted in a rich statistical discussion on risk levels but not a lot of understanding about how the CNS disease scientific knowledge base had grown. Now they have concluded that plaque is not the cause of AD.

So, in order to practice such detailed trials at P2/3 the designers must conduct (this is the tricky part) a detailed upfront analysis of the (CNS) disease based on data and best available science. In AVXL case w/A2-73 and AD this requires an intensive review of complex-patient based/disease based facts using AI tools never previously used in such cases. This approach puts the patients and the clinicians in a better informed and lower risk scenario altogether. This approach puts a lot more stress on knowledge going into the trials vs other. If you have incomplete data you should not start P3. Since some of my money is being put at risk here I am happier.

I like this b/c it puts the pressure where it belongs on the people who are designing the trials with an emphasis on DD. Old school trial and P3 go/no go has got us zippo, nada, ugatz.