Amarin Corp Plc (AMRN)

[veteranseabee]

SB,

This may not fully answer your question but it is from the FDA website:

a. FDA representatives at the late-cycle meeting are expected to include the signatory authority for the application, review team members from appropriate disciplines, and appropriate team leaders and/or supervisors from disciplines for which substantive issues have been identified in the review to date.
b. For applications that will be discussed at an AC meeting, the following parameters apply:
i. FDA intends to convene AC meetings no later than 2 months (standard review) or no later than 6 weeks (priority review) prior to the PDUFA goal date. The late-cycle meeting will occur not less than 12 calendar days before the date of the AC meeting.
ii. FDA intends to provide final questions for the AC to the sponsor and the AC not less than 2 calendar days before the AC meeting.
iii. Following an AC Meeting, FDA and the applicant may agree on the need to discuss feedback from the AC for the purpose of facilitating the remainder of the review. Such a meeting will generally be held by teleconference without a commitment for formal meeting minutes issued by the agency.
c. For applications that will not be discussed at an AC meeting, the late-cycle meeting will generally occur not later than 3 months (standard review) or two months (priority review) prior to the PDUFA goal date.