Amarin Corp Plc (AMRN)

[sharinky]

You are probably right. This document makes it sound like there is a internal mid cycle meeting and then one in which the applicant is involved.

5. Mid-Cycle Communication: The FDA Regulatory Project Manager (RPM), and other appropriate members of the FDA review team (e.g., Cross Discipline Team Leader (CDTL)), will call the applicant, generally within 2 weeks following the Agency’s internal mid-cycle review meeting, 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-cycle communication. Scheduling of the internal mid-cycle review meeting will be handled in accordance with the GRMP guidance. The RPM will coordinate the specific date and time of the telephone call with the applicant.