Amarin Corp Plc (AMRN)

[HDGabor]

A-

I think you presented a pretty reasonable timetable

I do not think … the timetable was wrong … see my next post

I think the late-cycle meeting has already occurred, which is when an AdCom was decided … 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

In this case which is your scenario:

(i) Amarin received the background package for the late-cycle meeting … participated in the late-cycle meeting: was aware of the AdCom decision … BUT … said (by July 31) the AdCom is unlikely and was "surprised" by Aug 8

or

(ii) Amarin did not receive the background package for the late-cycle meeting … did not participate in the late-cycle meeting

or (meanwhile it is not your view)

(iii) the late-cycle meeting was not held yet

I have a suspicion that the citizen petitions filed by MRC are coming into play because

Absolutely nothing …

(i) 08 Jul 2019 Citizen petition:

Medical Research Collaborative respectfully requests of the Commissioner that ethyl ester, re-esterified triglyceride, free-fatty acid (aka “carboxylic-acid”), mono- and di-glyceride forms of omega-3 fatty acids be officially ruled by the FDA as being dietary ingredients

Does not have any relevance / relation to the sNDA.

(ii) 09 Jul 2019 Citizen petition

Medical Research Collaborative respectfully requests that the Commissioner have Amarin Corp.’s U.S. Patent No. 8,188,146 (the ‘146 patent) removed from the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, for being improperly listed therein.

Does not have any relevance / relation to the sNDA.

(iii) 17 Jul 2019 Citizen petition (Long "Actions Requested" so I call it as "MO".)
It is the only one that related to the sNDA, but:
- It does not include any new information (please note: MRC's play with numbers - like calculating the pre-statin level based on current level and statin intensity - isn't an information)
- FDA made its analysis re. the "Placebo Group Effect" and it was done (started) prior this CP … as they did in case of MARINE and ANCHOR also … and they accepted the result of both studies, they found the comparison between the arms as adequate.
- a lot of "mistake" in the CP (e.g. when the DMC were instructed to monitor "MO") …"Yet, by the time FDA had reviewed ANCHOR data and expressed its concerns (late 2013/early 2014), the REDUCE-IT trial already had around 6,000 subjects randomized and had been ongoing for nearly 2-years."
(a) "The FDA, early on in the course of the REDUCE-IT trial, directed the independent data monitoring committee, or DMC, for REDUCE-IT to periodically review unblinded lipid data to monitor for signals that the placebo might not be inert"
(b) 6,000 was reached in October 2013 only
(c) majority (>50) was in the study less than 6 months (IIRC >75% less than a year)
… and so on.

Best,
G