Replies to post #198002 on Amarin Corp Plc (AMRN)

[ggwpq]

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

https://www.fda.gov/media/78941/download

Bottom line, probability of adcom is less than 3% as of this moment. If no news by next Friday, then no adcom for sure.

[HDGabor]

M-

the day-74 letter did too (they will almost certainly have received it by now). This notice of intent or non is not information that needs to be publicly disclosed

As of June 21, 2019 2:00 pm EST:

We still have not been apprised by the FDA as to whether or not we will have an adcom

Best,
G

[rafunrafun]

MRC / PYRRHONIAN:

The most likely window in which the FDA will inform the applicant (Amarin) of an AC date is between June 26 - July 10, based on precedent.

Narrator:

Today is July 9

:-) :-) :-) :-)