Anavex Life Sciences Corp (AVXL)

[stealthways]

Tauhydrae talking on a non-avxl board a few days ago:

"The FDA has been recommending adaptive trial designs as a way to cut cost and speed up new drug development. Safety and a tolerability were primary endpoints, and maybe bio-availability. Efficacy was a secondary endpoint as proof-of-concept. Powering a trial with hundreds or thousands of patients would be time-consuming to recruit patients and be very expensive, especially if no efficacy was found. So it's a small Phase 2a trial to quickly determine how many patients would be needed for a Phase 2b or Phase 3 trial to prove statistical significance. Perhaps also the data would be examined by the FDA to determine whether some form of accelerated approval is warranted or what would be needed next to get that.

What's interested me about the trial is they did the Mini Mental State Examination (MMSE), event-related potentials (ERP) and P300 tests, and Cogstate battery and found improvements on all tests and for every dosage of A2-73. I find that remarkable.


Professor Paul Maruff (CSO of Cogstate) said “The Cogstate tests measure people's ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p."