Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I think you're mistaken, Doc. See my post here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173460549

While the "EMA recommends providing the eligibility request preferably ... at the latest, 7 months before the MAA is filed," I believe that's in part to give CHMP time to do what it has already done. I think Boi said CHMP is given six months to decide if the MAA can go forward, but it did it in ONE MONTH.

I don't know, but I'm inclined to believe, that the Bard reply I posted is correct (and not due to WGT bias; I'm frequently accused here of being short). If Bard is right, we'll have the MAA filed before March 2024!

Furthermore, I've read (though can't find at the moment), that the EMA may shorten the 210 days for decision-making to 150 days for illnesses where there is widespread significance for public health (or something like that).*


EDIT: Found it. "On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment. ...
Applicants for accelerated assessment should justify their claim that the medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation."
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment