Anavex Life Sciences Corp (AVXL)

[Doc328]

Sometimes if a medication is already approved for one indication, a company can get approval with just one phase 3 if results are good --- that's how rivastigmine got approved for PDD with a single 530 patient phase 3 (they also had a smaller phase 2 for PDD). They had already done 2 large phase 3 studies to get approval for AD earlier. If AVXL gets approval for Rett maybe they could get by with a single phase 3. However, IMO, Rett is so different than AD / PDD that I would expect 2 phase 3's would be needed for either AD or PDD and then one phase 3 for the other indication if approved. I doubt any regulatory agency will act on the current 132 patient PDD trial results. However, data will be very useful to design a good phase 3.