Amarin Corp Plc (AMRN)

[sts66]

NOt sure about the answers to any of your questions, that's why I asked the ones I did - for one, I would assume that the term OTC varies by definition per country, meaning what the FDA says is GRAS or OTC may not be the same as what Japan calls it. For instance, codeine (Tylenol 3) is OTC in the UK, and low dose diazepam is OTC in Mexico.

I also don't know how you get a product into the US to sell it as OTC - I know there are limitations on advertising and making medical claims, but not aware of how one goes about actually importing and selling something. If they sell Epadel OTC they really don't need patent protection in the US, but then again they wouldn't be able to market it for lowering TGs either, they'd violate AMRN's patents and FDA marketing rules. Guess what I'm really wondering is "does OTC Epadel have the potential to reduce global sales of Vascepa?".