Replies to post #175775 on Amarin Corp Plc (AMRN)

[BaaBaa45]

The complaint alleged that concentrated omega-3 products sold in the US as dietary supplements are not in fact “dietary supplements” under the FD&C Act, but instead, are “unapproved new drugs.”2 Therefore, according to Amarin, the “false labeling” of these products unfairly competes with Vascepa, constituting “an unfair act and/or unfair method of competition under Section 337 because, among other things, these acts violate Section 43(a) of the Lanham Act, 15 USC 1125(a) and the standards established by the FD&C Act.

ok, so not so much the medical use point - more nuanced than that....

https://www.raps.org/news-and-articles/news-articles/2018/7/update-on-the-amarin-itc-case-and-the-issues-at-st

[BaaBaa45]

A little too much caffeine this AM. May have now stirred up a hornet's nest. Will go and hide for a day or so......!

[Biobillionair]

Never has the FDA been as blatant with the "fish oil" warning...NEVER.

On the webpage titled, “Omega 3 Benefits Stroke – Fish Oil Supplement May Help”:
Fish oil supplements have been shown to have anti-inflammatory effects in diseases such as cancer, asthma, rheumatoid arthritis, osteoporosis, dry eye disease, age-related macular degeneration, coronary heart disease and sepsis.”
“The use of fish oil supplements as a protective factor against stroke and other neurological diseases such as Alzheimer’s has been suggested.”

The above quote provides ammunition for Amarin's legal team to prosecute any miss-use of the pending sNDA Vascepa for Cardiovascular "Rx.". This is a significant move forward on the part of the FDA.

BB