Amarin Corp Plc (AMRN)

[Biobillionair]

The BIG picture in ITC appeal case...IMO the ITC is "OK" with being ordered to investigate and the "proposed intervenors" protest too much to be innocent.

The FDA is moving fast, yes actually fast, by disbanding "Food Ad Com" 12-12 and releasing new GRAS guidance 12-14. Here's the new guidance documents:
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM585027.pdf and https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM584930.pdf

I'm not sure if these actions were sparked by Amarin getting active with comments to Public Meeting to Discuss the Development of a List of Pre-DSHEA Dietary Ingredients or if it's the combined comments and ITC appeal, but the FDA is acting swiftly.

Amarin comment to Public Meeting to Discuss the Development of a List of Pre-DSHEA Dietary Ingredients was posted 12-4 and can be found here: https://www.regulations.gov/docket?D=FDA-2017-N-4625

Conclusion:
I belive ITC will "request" appeal order to rule on mandamus ASAP, perhaps before "oral" arguments. Obviously if this occurred the appeal will be dismissed and ITC begins a full and fair investigation of the illegally labeled "DS" that have significantly damaged Amarin. IMO this could occur as early as next week clearing this case from the appeals docket. The new GRAS guidelines could prove to be a very negative development for the "proposed intervenors".

Any questions or arguments are welcomed...

BB