Replies to post #230295 on Amarin Corp Plc (AMRN)

[louieblouie]

MONDAY!!!!!

[Atom0aks]

This means Woodcock is ready to approve the sNDA. All denial letters precede sNDA approval. Cheers!

The letter says the CP was denied due to a technicality and has nothing to do with the sNDA,

Because your request disputes the appropriateness of listing the '146 patent and urges FDA to remove it from the Orange Book, your request is subject to the procedures and requirements set forth in our regulations at 314.53(f). Submission of your request to FDA in a citizen petition does not comply with those procedures, and we are unable to resolve your concerns in a citizen petition response.

Source: https://www.regulations.gov/document?D=FDA-2019-P-3265-0003

Source for mentioned regulation: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.53


The other two CP he submitted, one of which pertains to the sNDA (submitted 7/17/19), are still pending.

[Biobillionair]

Marz- And Woodcock didn’t sign that letter. Whomever signed it did it for her...it’s dated today...very interesting.

BB

https://www.regulations.gov/document?D=FDA-2019-P-3265-0003

[Atom0aks]

This means Woodcock is ready to approve the sNDA. All denial letters precede sNDA approval. Cheers!

Looking back, it appears there is some truth to that. Amarin received a CRL on April 27, 2015 (hyperlink). On that day, the FDA denied all 22 citizen petitions (see FDA-2013-P-1612-0429 thru FDA-2013-P-1612-0453).

Currently, there are two citizen petitions still open that were submitted by MRC. While keeping an eye out for denial letters may warn us in advance of sNDA approval, I don't know how predictive it will be if history repeats itself and they accomplish both on the same day.