Replies to post #347614 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

Gernee20 ... You make a very good point. I had not considered that.

With both data sets in hand a single NDA should suffice. The possible difference in age prescribing would then become a labeling issue that would be covered in the NDA.

[end2war]

One small thing to note is only one nda would be needed when applying for BOTH pediatric and adult Rett syndrome approval.

Can you offer any authority for this claim?

Are there not special legal requirements to obtain regulatory approval for a pediatric indication in the US?