Amarin Corp Plc (AMRN)

[pickletrades]

HDGator - Not sure where you are getting 60 days... This is what I'm seeing the Dispute Resolution Guidance:

263 1. Timelines for Reviewing Formal Dispute Resolution Requests for Human Drug Applications Covered by PDUFA

266 If a procedural or scientific dispute concerns a human drug application covered by PDUFA, the FDA should complete the review and provide a decision on the appeal within 30 calendar days from receipt of the appeal. The FDA should respond to the sponsor within the 30-day window in writing or by telephone (i.e., 30-day response). If the response is by telephone, the FDA should follow up with a written confirmation within 14 calendar days of the verbal response.

272 If a sponsor requests a meeting as part of its appeal, the meeting request should be treated as a Type A meeting. Under the PDUFA meeting goals, the FDA should either grant or deny the meeting request within 14 calendar days of receipt of the appeal. If the meeting is granted, the FDA has 30 calendar days after the meeting date to provide a decision on the appeal. This time period allows the FDA to consider the discussion at the meeting in its decision making process.

30 days response from the meeting plus 14 days to grant/deny the meeting would be at most 44 days from the meeting request. It goes on to say it could be delayed if the FDA needs clarification.

IF they requested the meeting Jan 21 (when DMEP made their decision) then ODE II response should have been last Friday (unless delayed for clarification).

Can you point out where you are seeing 60 days?