Replies to post #440172 on Anavex Life Sciences Corp (AVXL)

[abew4me]

It's my opinion that TGD wants to make sure the FDA has accepted our NDA before he announces the TLD for Rett.

[Investor2014]

Not many companies will PR an IND, which requests the FDA's go-ahead to trial a new drug in humans and must be filed prior to a P1 trial. An NDA on the other hand is pretty much always PR'ed as it signals a timeline for a drug to either be rejected or receive FDA marketing approval.

A PR for initiating a clinical trial will have been preceded by filing an IND. Once a trial is initiated and then receives a clinical hold letter, it is PR'ed as a material event since a pipeline drug may disappear from the company's future prospects.