Anavex Life Sciences Corp (AVXL)

[Mikesc]

Building on work that was already underway at the Agency, the Cures Act specifically calls on FDA to assist sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs and biological products to facilitate more efficient product development.

Along with Dr. Gotlieb's comment about 5 CNS guidances being issued before the end of the year.

And TGD stating in a 10 or 8K the trials would be a first ever.

I think Anavex may be the prototype....