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MedResCollab

07/09/19 9:35 AM

#200458 RE: rafunrafun #200452

Yes, most likely window. Later is still quite possible (through next week even). After the 22nd very unlikely. That is because the mid-cycle review took place on or around June 28th, and the FDA sets a goal of "within two weeks" from that review to communicate the content of the review with the applicant that they can share, and that may assist with the review process. Sometimes the mid-cycle review occurs a bit earlier than exactly "3 months" for priority reviews, and the mid-cycle communication sometimes comes early in the "within two weeks" window. So, for Amarin, 6/26 - 7/10 is a most likely window. It is still not improbable for the mid-cycle communication to come on the 12th, or 15th, or 18th for Amarin.

If we get through 7/22 and no word on AC meeting, then there probably won't be one.

Regards,
-MRC