Amarin Corp Plc (AMRN): Ziploc- that was totally cool to see you...

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SonamKapoor

Re: ziploc_1 post# 232331

Monday, 12/09/2019 12:53:18 PM

Monday, December 09, 2019 12:53:18 PM

Ziploc- that was totally cool to see you on the ADCOM video testifying last month. Nice!

Just to clarify, regarding OMACOR (a drug) in Europe, they said it was not effective at 1 g/day for preventing further heart or blood vessel issues in patients who have had a heart attack. See STS post from 12/14/18 #167148. That decision was appealed to the EMA by BASF and then on March 28th they let their December decision remain. See BiotechRes post#184278 & STS post#184454. As far as I know, OMACOR today is still approved for reduction of >500 TGs in Europe.

www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-assessment-report-following-re-examination-procedure_en.pdf

Both O-3 drugs and DS are legal in Europe, Japan and Korea. As they currently are in the US, too.

Different Market/Product Regulatory Categories
Branded Drugs - Lovaza/OMACOR, Vascepa, Epadel, etc.
Generic Drugs - generic Lovaza, generic Epadel
OTC drugs - none?
Medical foods - Hepacor, etc
DS - too many to list
Food - fish, algae drinks & smoothies, infant formula, etc.