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Re: Steady_T post# 444170

Tuesday, 12/26/2023 3:29:16 PM

Tuesday, December 26, 2023 3:29:16 PM

Post# of 463647
I read the timetable more optimistically than you do. I read it that "Notify[ing] EMA of the intended submission date (letter of intent)" starts the 7-month clock running*; so it started running before the EMA/CHMP agreed to Anavex submitting a MAA. We know Anavex submitted its letter of intent by November 20, so the 7 months (actually 7 months is the minimum; the timetable says 7 to 18 months) started running no later than November 20; and it's possible Anavex submitted the letter of intent well before it PRed it. The submission of the MAA may be much closer than 7 months. (OTOH, it could occur as late as almost 17 months from now; I'm inclined to believe it will be much sooner than that, probably within two to six months from now.)

* see https://learning.eupati.eu/mod/book/tool/print/index.php?id=893&chapterid=822

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