Amarin Corp Plc (AMRN)

[sharinky]

Mid cycle review meeting that happened Friday does involve the applicant. They would have had an agenda prior to the meeting and an opportunity to provide additional information.

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.


https://www.fda.gov/media/108746/download