Replies to post #230588 on Amarin Corp Plc (AMRN)

[sts66]

Yeah, I got two of the CP's mixed up because of that Woodcock letter to the USPTO saying it was too late to file a '146 patent CP, then yesterday the FDA formally denied the CP - both communications were about the same patent, but apparently meant different things - maybe that the USPTO could not accept a CP against that patent if one was filed?

Found a good source of CP's trying to figure this all out - link is to an xlsx file containing all CPs filed from 2007 to current, one worksheet for each year

www.fdalawblog.net › wp-content › uploads › CPTracker

Shows these two are both open - 1st one it claiming EE-EPA is a DS or should be classified as one, 2nd one is the MO CP:

FDA-2019-P-3266 Medical Research Collaborative LLC Carboxylic-acid

FDA-2019-P-3424 Medical Research Collaborative, LLC VASCEPA (icosapent ethyl)

[VuBru]

Atom -

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

MRC is tilting at windmills! The ITC lawsuit was totally focused on the inability of the FDA to make this determination (one way or the other), and a CP is certainly not going to change the glacial speed that this issue is being addressed. They clearly are in no rush to decide it.