Replies to post #442860 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

YES, Fast Track designation exists for Rett. With this in mind, do you think a rolling review of an NDA might be currently underway

Good luck and GOD bless,

[Steady_T]

It is certainly possible although Anavex has not released any information on that.

It is important to understand that rolling review does not shorten the time for approval. The 6 months clock for an FDA decision doesn't start until the last section of the NDA is submitted. What rolling review does is allow the FDA to examine the submitted sections and determine if there are any questions or requests for additional information concerning the submitted sections. Ordinarily such requests or questions would add time to the 6 month decision clock. So getting those issues, if there are any, out of the way before the 6 month clock starts keeps the 6 month timeline intact.