Replies to post #230586 on Amarin Corp Plc (AMRN)

[Atom0aks]

No, only one remaining unanswered CP from MRC, the one about MO - the one where he tried to get V classified as a DS was filed after a deadline had passed and was rejected. I don't seem to have saved the letter PDF from Janet (or can't find it), but I'm pretty sure BB knows where it can be found online. Might have been sent to another government agency and not to MRC.

I don't think so, the docket says it's still open,

Requests that the FDA require 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

Docket ID: FDA-2019-P-3266Agency: Food and Drug Administration (FDA)Parent Agency: Department of Health and Human Services (HHS)
Summary:
OPEN

Source: https://www.regulations.gov/docket?D=FDA-2019-P-3266

[stu_har]

sts, I thought so also, but Atom provided links to them. I missed one as I was sorting by Product Name (V), there is one under Carboxylic Acid.

[Atom0aks]

Found it - but now I'm confused at why FDA issued a new CP denial letter over the '146 patent since Janet told the USPTO time to file a CP had elapsed:

https://www.regulations.gov/contentStreamer?documentId=FDA-2013-E-0780-0006&attachmentNumber=1&contentType=pdf

Because I think you may be confusing the two. Here is the link to the docket your letter pertains to,

https://www.regulations.gov/docket?D=FDA-2013-E-0780

Here is the link to the docket pertaining to MRC's petition,

https://www.regulations.gov/docket?D=FDA-2019-P-3266