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Re: ggwpq post# 198481

Wednesday, 06/26/2019 7:24:28 AM

Wednesday, June 26, 2019 7:24:28 AM

Post# of 424782
I see that was a bad example. I still think an early approval is a real possibility. This Friday, June 28th is the scheduled mid cycle review meeting. Amarin should be laser focused on that the rest of this week. If they successfully get the FDA everything else they are looking for, good things will happen.

"As set forth in guidance issued pursuant to Section III(A)(1), the Project Manager and other appropriate members of the FDA review team will call the applicant to provide the applicant with an update on the status of the review of their application. An agenda will be sent to the applicant prior to the mid- review-cycle meeting. The Project Manager will coordinate the specific date and time of the telephone call with the applicant. "
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