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Bourbon_on_my_cornflakes

01/16/24 2:49 PM

#448033 RE: sab63090 #448030

Seems odd to me that they would even need 7 months to accomplish something that the EU recommended Missling to do



Agree. The NDA should be filed Feb'ish. If it isn't, there's a problem.

Steady_T

01/16/24 4:19 PM

#448056 RE: sab63090 #448030

The EMA timelines have been posted several times. That is the EMA procedure. Why it takes the EMA that long before they are WILLING TO ACCEPT an MAA is up to them. Their procedure says during that 7 months they are getting the rapporteurs selected and there are discussions that go on during that period.

https://learning.eupati.eu/mod/book/view.php?id=893&chapterid=822