Replies to post #210178 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Thanks HDG. Interesting that it seems the last week of October Amarin will receive a “draft question”. Hopefully that question does not change much over the following two weeks.

Anyone know if the draft question before Anchor ADCOM changed?

[dmlcento]

HD, perhaps I am misremembering, but didn't the FDA change the "final" question during the actual Anchor AdCom? Didn't they ask a different question during the AdCom then was put out two days before the meeting?

[Atom0aks]

Furthermore they will have a late-cycle meeting on or before November 1. ("For applications that will be discussed at an Advisory Committee meeting, the late-cycle meeting will occur not less than 12 calendar days before the date of the AC meeting. … The background package for the late-cycle meeting should be sent to the applicant not less than 20 days before the meeting if an AC is to be held")

I think you presented a pretty reasonable timetable, however, I would like to argue that I think the late-cycle meeting has already occurred, which is when an AdCom was decided.

For applications that will be discussed at an Advisory Committee meeting, the late-cycle meeting will occur not less than 12 calendar days before the date of the AC meeting. 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 2 months (priority review) prior to the PDUFA V goal date.

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

It is my hypothesis that the FDA was working on a No-AdCom timetable. This means that the late-cycle meeting would have occurred somewhere around July 28, at which time if they decided to hold an AdCom, it would explain why Amarin was notified of an AdCom on August 8.

As I mentioned in a previous post, I have a suspicion that the citizen petitions filed by MRC are coming into play because they were filed in early July. Their submission would have fallen between the mid-cycle and late-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.

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

Therefore, if the petitions brought up a concern the FDA thought was worth addressing, it would have been discussed during the late-cycle meeting. There are a lot of references to work through in all three petitions, so if someone has a summary already prepared, I am all ears.

08 Jul 2019 Citizen petition (https://www.regulations.gov/document?D=FDA-2019-P-3266-0001)
09 Jul 2019 Citizen petition (https://www.regulations.gov/document?D=FDA-2019-P-3265-0001)
17 Jul 2019 Citizen petition (https://www.regulations.gov/document?D=FDA-2019-P-3424-0001)

[HDGabor]

Correction

based on November 14 and the Guidance:

27/08: The FDA explains the meeting’s focus to the sponsor and also may advise the sponsor about the information it may wish to include in its briefing materials

14-24/10: The FDA will send a copy of its briefing materials (or relevant portions thereof), as prepared for public release, to the sponsor to review. … inc. the draft question

25/10-31/10: The sponsor should review FDA briefing materials (or relevant portions thereof), as prepared for public release.

12/11: The FDA will post on its Web site both the sponsor’s and the agency's publicly available briefing materials.

Furthermore they will have a late-cycle meeting on or before November 1. ("For applications that will be discussed at an Advisory Committee meeting, the late-cycle meeting will occur not less than 12 calendar days before the date of the AC meeting. … The background package for the late-cycle meeting should be sent to the applicant not less than 20 days before the meeting if an AC is to be held")

Best,
G