Anavex Life Sciences Corp (AVXL)

[Steady_T]

Maybe. Maybe not. If Anavex is pursuing a rolling submission combined with the other benefits of Fast Track designation Pediatric Rett could be approved before AD.

AD does not have Fast Track which means it is likely to take the usual 9 months after NDA submission for the FDA to rule on the NDA. Combine that with the time it takes to analyze the data and prepare the NDA and you are looking at a year plus from now for approval.

Pediatric Rett finishes at end of year. 3 months to analyze data. 2 months to finish the NDA since much of it can already be done. Less than 6 months for the FDA to rule on the NDA. Why less than 6 months. Rolling submission means that the FDA has already been processing various sections of the NDA.

So there is a path for Pediatric Rett to be approved before AD. The $100,000,000 is a bonus.

Now if the FDA decides to do accelerated approval on either Rett or AD all bets are off and the timeline to approval is much shorter.