Anavex Life Sciences Corp (AVXL)

[falconer66a]

Clinical testing of blarcamesine for insomnia.

In Pharma trials, is it possible to submit a NDA based on secondary endpoint being successful? Sleep in all of these trials has always been a secondary endpoint,....

I don't know. Someone who knows the mechanics of drug trials will have to tell.

However, there are prescription drugs approved for the treatment of insomnia. And they have big side effects. Blarcamesine may work just as well or better, and certainly won't have any severe or obviating side effects. Most likely, a new drug trial would be needed, testing (and proving) blarcamesine as a new soporific drug, to compete with existing soporifics such as the ones listed here: https://www.webmd.com/sleep-disorders/insomnia-medications

The costs of insomnia are in the billions:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2625324/