News Focus
News Focus
icon url

Hosai

11/23/24 2:57 PM

#474790 RE: 12x #474788

Where does it say 25th Nov is final submission deadline?

From what I've seen companies often submit about 2-3 weeks before their application is "accepted". They tend to PR the acceptance on the same day as ends up being their start date or a few days after the start date. There is a new start date per month and usually 6-7 companies share that start date.

Going by prior years it looks like the last 2 start dates for this year would be around Nov 28th and Dec 27th so assuming they have already submitted it would mean an acceptence PR on Fri 29th or Mon 2nd or if not would be late Dec/early Jan for acceptance PR (though they could PR that they have submitted if if they submit in Dec as some PR when they submit rather than upon acceptance).
icon url

frrol

11/23/24 4:47 PM

#474798 RE: 12x #474788

The current monthly list, dated 11/7, shows which MAA submissions have been started by the EMA to date. Five were started as of 10/31 (submitted by 10/14). The next 'start date' is 11/28. If we've submitted by 11/11, we will hear on 11/28 or next business day. (If we haven't, we'd have to submit by 11/25 to meet the "2H 2024" company milestone.) The 10-K completion and release is irrelevant for any of this. Let's see what we hear on 11/28 or 29.