Amarin Corp Plc (AMRN)

[sts66]

Amrn needs to sponsor a bio equivalent trial on all available gv's

Wouldn't get anywhere, or would take so long for FDA to take action our patents would expire in the US. I forget the name of the drug, but it was an antidepressant or anti-seizure in extended release form - patients started complaining about the generic right after it came out, but it took the FDA something like 9-10 yrs before they tested it and showed it was not equivalent to the brand name and could be harmful to patients. IIRC some of these people taking the generic became suicidal - that's a major problem - didn't matter, FDA dragged their feet as long as they could. Even if AMRN ran those tests and found significant differences they'd then need to show it was harmful to patients - I don't know how you prove that with EPA.