Replies to post #171890 on Amarin Corp Plc (AMRN)

[couldbebetter]

A: Money! Vascepa is worth much more as an FDA approved medication
for CVD. Another reason is because doctors want to do everything
within their power to keep their patients healthy. Having Vascepa
in their arsenal of drugs will mean they can determine if their
patient meets the parameters for the drugs effectiveness and then
prescribe it to them. Afterwards, they can monitor their patients
progress over time with the drug. Generally speaking, if a doctor
tells their patient they should take a particular drug because it
may save their life or reduce their odds of getting a heart attack or
stroke, they will do it. Whereas, taking a DS is voluntary, and
in the patients mind probably not as important as being prescribed
a drug. If Vascepa were an OTC DS, it would be one of thousands...
being an effective Omega-3 CVD medication makes it one of one.

[Nukemtiltheyglow]

Notademoc; no such thing as a stupid question. Following up Cbb great Post, I can only add that Woodcock (FDA), actually had no problem with Amarin marketing Vascepa as a dietary supplement (DS). This was contrary to what Amarin management wanted to do. Which probably prompted the 1st Amendment court decision. Which Amarin summarily won. Hindsight says this was the right decision by Amarin to rightfully market Vascepa as a drug vs a Dietary Supplement.

[sts66]

Erm....because it's a drug? And by FDA/FDCA definitions it cannot be a DS, which is part of their ITC argument. I assume you didn't mean selling it OTC, and answer to that is obvious - cost would be too high and couldn't be offset by insurance - AMRN couldn't have helped fund R-IT if they lowered the price to a point where consumers might actually be willing to pay for it out of pocket. Plus FDA probably wouldn't have agreed to let them sell it OTC w/o any long term safety studies in hand, and they'd have made the right decision given the surprising increase in A-Fib in the V group.