Anavex Life Sciences Corp (AVXL)

[ClosetInvestor]

Maybe the painter and pianist can do a duet for the FDA and that will get early approval? Nope, not going to happen because we need data. Using the word cure is too early, no matter what tense or form it's in. The results are promising but the phase 2/3 data must be good in order for the FDA to grant breakthrough designation. I get it, the FDA helped design the phase 2a, but the cognitive measurements are secondary end points and not the focus of the trial. There just aren't enough patients to solidify the patients cognitive results as 100% legitimate, especially because it's an open label study. The data will help design a streamlined phase 2/3 but nothing more.