Anavex Life Sciences Corp (AVXL)

[sokol]

Is it realistic to think that a clinical trial AVXL 2-73 for Rett a rare disease for which no treatment exists, for which Orphan status is granted by the FDA, which the Rett Foundation (THE ”rare disease patient group” for Rett) supports the trial with it's funds at risk, for a drug that so far has been proven safe in other clinical trials, and for a clinical trial that is set up and ready to go at treatment centers that desire to do this trial using AVXL 2-73 to treat this awful disease will not occur?

”The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.” https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htm

The FDA has already determined all as set forth in the above paragraph in granting the Orphan Status for AVXL 2-73.

So again, is it reasonable to speculate that the AVXL 2-73 trial will not take place? Is it reasonable to speculate that the Rett trial will be delayed into 2019 or 2020 or commence sooner? I do not think so.