It looks like the FDA is allowing Vascepa even though it closely resembles GSK's product,
IMO V and L are nothing alike: V = A, while L = A + B, and B in high amounts is bad for you! Then throw in all the IP that V has that L doesn't, and it's clear they are two totally different drugs.
it is allowing Vascepa to exist and sell, and it is asking (via AdCom) to continue testing to see if it will Reduce CVE's...
They had no basis for not approving the MARINE indication. And asking for AMRN to continue R-IT while cutting them off at the knees by denying ANCHOR (yes, AMRN asked for too much on the label, but still), is the height of arrogance - "we don't care if you go bankrupt, but please continue to spend millions on your own dime because we really want a final answer to this question".
"It is also allowing Vascepa to do additional testing for other conditions like Dry Eye, Inflammation..."
FDA cannot control what a drug company wants to do with their drug in additional trials as long as it is deemed safe for the patients in the trial. And I'm not aware of AMRN doing any trials on their own for any other indications - there are some independent trials going on, like the Thetis V + metformin trial:
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