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Re: None

Tuesday, 03/05/2019 5:17:17 PM

Tuesday, March 05, 2019 5:17:17 PM

Post# of 425262
EU submission deadlines

In case folks were wondering, EMA is different than FDA in that they’ve got a calendar of strict submission deadlines for marketing applications. Upcoming ones Amarin is looking at for their filing:

May 6
June 3

What this means is that if Amarin were to submit on May 7, one day after current deadline, it would be no different than submitting on June 2, the day before the next deadline. EMA starts their review of all submissions filed by that deadline after it passes. As previously mentioned, I expect them to hit one of these next two deadlines.

After this it would be 7/1, 7/29, and 9/16. But this would be a major operational failure if the MAA bleeds into late July. Hitting 7/1 would be ok, but it can be done much quicker.

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