Replies to post #39398 on Amarin Corp Plc (AMRN)

[louieblouie]

The time clock is that it is 6 months overdue. Its on the 'it raises complex issues requiring extensive review and analysis by the FDA' timeline.

But first the FDA reviewers and analyzers must find their heads which have been somewhere up their @sses for the last three years. They're still looking.

[Biobillionair]

MontanaState83 EPADI CP "should" be answered by Wednesday!

The FDA has 180 days to respond to a Citizen Petition. The LAW was changed from 180 to 150 days in 2012, but the FDA only this month released guidance acknowledging this change. This change only refers to special 505(q) petitions.

"The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 2012.7 Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two ways. First, it shortened from 180 days to 150 days FDA’s deadline for responding to petitions subject to section 505(q). Second, with the exceptions noted below, it expanded the scope of section 505(q) to include certain petitions related to biosimilar applications"

"Original" EPADI CP are dated December 6, 2013 with received letters of December 11th and a file date of December 13th.

180 days Regulatory limit for response due June 11th, 2014.

FDA responded with an interim response, June 6th, 2014. They cite complex issues and extensive review as excuses for needing more time as provided by Regulation 21 CFR 10.30 (e) (2).

"(iii) Provide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished."

On June 6th, essentially the FDA claims a dog ate their homework. It took the FDA only 13 days after the Ad Com to rescind Anchor SPA, it would seem that it was highly prioritized at this time to come to such a quick solution. Also, in coming to this quick decision the FDA conveniently skip SPA guidance in written communication to the sponsor and scheduling a type A meeting. I can assure you, a Judge will take this into consideration when/if this goes to court.

After June 6th the FDA also communicated with stakeholders after numerous letters and push back from Congressional Members, this letter is dated 7-31-2014. Here: http://www.regulations.gov/contentStreamer?objectId=09000064817f23e8&disposition=attachment&contentType=pdf

Assuming the FDA "needed" 180 days to respond from June 6th, the next due date is December 3rd 2014.

BB