Replies to post #431491 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

How long do you think it takes to write an NDA for a drug with a new MOA?

[Investor2014]

No NDA will be submitted this year imo.

For AD Missling is still in considering to have an AA pathways discussion with FDA. Those considerations are linked to procrastinating over how best to represent a so far unusual way for the FDA to look at the P2b/3 results and probably further biomarkers than the two in the recent PR.

Rett in principle could be filed this year provided the results are clear in a to protocol traditional manner and a proper rolling submission has been taking place. Maybe Anavex have been filling on a rolling basis and maybe the results are strong with straightforward traditional TLR/TLD, but given precedence my best guess is Q1 next year.