Anavex Life Sciences Corp (AVXL)

[sokol]

Gburgin, the answer to your question about whether significant and successful off label use for AD (once AVXL 2-73 is approved for Rhetts) would bring in the generic makers is no as long as any exclusivity is pending. No generic may be authorized by the FDA as long as any exclusivity is in force for AVXL 2-73 whether it be FDA exclusivity and/or patent exclusivity. Patents too are listed in the FDA's Orange Book in the FDA's ministerial capacity. As long as any patent for AVXL 2-73 is listed in the FDA's Orange Book, it will not authorize a generic version of AVXL 2-73 for any use.

Anavex may list a patent for AVXL 2-73 in the FDA's Orange Book after the Rhetts approval is granted and before any exclusivity expires. The 7 year FDA exclusivity period for approval of this drug for Rhetts gives Anavex 7 years to develop more patent protrction.

And yes, I do think that there may be additional FDA exclusivity for this drug for the treatment of Alzheimer's or any other disease besides Rhetts; however, I need to confirm this.