Anavex Life Sciences Corp (AVXL)

[WilliamMunny]

I agree with you, Hosai, that the wording is a bit vague. In my view they want you to request assignment of rapporteurs seven months prior to the MAA filing. It can come earlier, but they won't act on it until seven months away. For instance, if Anavex submitted a request for rapporteurs on 2 January 2024 with a projected filing date of 15 August, the EMA wouldn't take it up on the 10 January submission date but would wait until the 7 February submission date (which would be within seven months). At that point it would be less than seven months (but not much) and theoretically still give the company enough time to work with the rapporteurs before the filing. The monthly submission deadlines (except December) would therefore de facto set a minimum of roughly six months as I see it.