Please retract another of your erroneous statement, "The most likely window in which the FDA will inform the applicant (Amarin) of an AC date is between June 26 - July 10"
Please review the following, especially section 4.4:
4.4 Conduct Mid-Cycle Meeting The mid-cycle meeting is held by month 5 for Program and standard reviews(month 3 for priority reviews). The mid-cycle meeting provides an opportunity for management to review the work of the review team thus far in the review cycle. Objectives of the meeting are to: • Present status and key findings of all reviews, consults, and inspections. • Confirm the decision that was made regarding the need for an Advisory Committee meeting. • Identify any issues that could preclude an approval action. • Begin high-level discussion of labeling (e.g., are major claims supported) and need for PMRs and/or PMCs. • Determine if a REMS is needed (if not already determined) and, if so, the goals and the elements of the REMS. • Revise the review plan and interim timelines, if needed. • Solicit feedback from the signatory authority and other discipline directors. • For expedited reviews, discuss possible early target date(s) for completion of reviews and action