Replies to post #293261 on Anavex Life Sciences Corp (AVXL)

[boi568]

My intuition is that eventually Missling is going to file an overarching NDA for a large number of CNS indications. The way he is interweaving his proofs among AD, PDD, and Rett show a very ambitious goal. However, I don't think he is going to wait for that -- Rett alone will be first.

[Steady_T]

Much of the NDA for the three separate NDA's will be the same information.

The manufacturing facility information etc. will be the same. They might include the P1 data from all three trials in each NDA.

My understanding at this time is that an NDA would be required for each indication.

P2 & P3 information will be unique to each NDA as will the labeling and probably the dosing schedules.