Anavex Life Sciences Corp (AVXL)

[JB3729]

Hi F1ash, I knew I had read a statement saying the trial cannot be blinded. I finally remembered where I had read that.

If there are any insight that the company has shared about why they chose unblinded data that would be helpful as well.

Professor Maurice also wrote in a second email:

After carefully checking the mail I sent to you, I want to clarify some points that could be misunderstood:

1) The mail reflects only my personal thoughts, as a preclinical researcher involved in the pionnering work on the compound. I demonstrated the symptomatic and neuroprotective effects of the compound in several mouse models of AD. But I have no competence to discuss the clinical protocol used by the company.

2) In answer of question 1, I wrote "The idea is to be able to adapt the protocol and get the maximum information they can." It was too imprecise. To be more accurate, the current trial has been designed purposely by using state-of-the-art Population PK/PD and Adaptive Design. The "adaptive design" is only referring to dosing adaptations. Protocols itself can not be changed. Moreover, the design followed FDA guidelines (see below source). These trials cannot be blinded and do not required a control. Source: Professor Maurice provided links to these two sources (1, 2).
http://seekingalpha.com/article/3687706-anavex-interview-professor-tangui-maurice