Replies to post #450992 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

My guess is that the NIH means that the LOI triggers the 7-month countdown to the MAA. For EMA protocols, I'd certainly trust the EMA over an American agency's summary of the EMA procedure.

I'm sure the EMA documentation would reference the requirement that an applicant submit a "Centralised Procedure request" if there were such a thing.

[Investor2014]

That NIH document is from 2011 and the EMA made changes to their procedure in 2018.