Amarin Corp Plc (AMRN)

[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.