Amarin Corp Plc (AMRN)

[MedResCollab]

Looks like you missed it: mid-cycle review meeting WAS on 6/28 … the FDA could not "held off on the mid-cycle review altogether" … since it is history now. -HDGabor

It is likely that the mid-cycle review occurred already, and on around 6/28 (~3 months into review for priority review apps), we agree. However, only FDA knows this, and there is rationale in guidance for not holding the mid-cycle review, and deferring it for a later date. That is, if an extension to the PDUFA date has been determined as necessary before the review occurred:

Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date. If the planned date for discussion of labeling and PMRs/PMCs is changed, the RPM will notify the applicant. (See MAPP 6010.8)

For PDUFA V [and VI] “Program” applications [including current Vascepa sNDA], the new planned review timeline will include a new planned date for the internal mid-cycle review meeting, if appropriate, depending on when during the course of review the major amendment(s) is accepted for review. All other milestones are adjusted to the new goal dat

It is yet another possibility to consider. Though we think more likely that the mid-cycle review occurred and that the mid-cycle communication will take place within two weeks from that date, or sometime around/by 7/12 for Amarin’s sNDA review, although somewhat later is of course possible (into next week).

On the rest, we would refer you to our CP submission that covers the issues you raised extensively, in particular pages 45-55:

https://www.regulations.gov/document?D=FDA-2019-P-3156-0001

Regards,
-MRC