Amarin Corp Plc (AMRN)

[jessellivermore]

HK...

From your post: Quote

"(3) Every paper between 2000-2008 including American Heart Asssociation state of the art guidelines in treating Hypertriglyceridemia, and POSA state of the art reviews/ meta analyses say unequivocally that all omega3 formulations will increase LDL as a consequence of how VLDL is metabolized.Where is the obviousness or the hint of a soupcon of evidence that EPA could do it without increasing LDL and lowering ApoB anywhere inthe litearture? As the Curfman article points out, MORI taught nothing and quite possibly taught the opposite of what Du thought it did."

Let me just include one other piece of evidence..And that would be "Lovaza" which was the number one Omega three trig lowering drug, and may still be..Attempted to seek an FDA label expansion (sNDA) for trigs over 500mg/DL during the stated time frame and received a CRL* (* Complete Response Letter) from the FDA because although Lovaza was actually more effective on a per dose basis than Vascepa, at lowering trigs. Lovaza raised LDL-C to the extent FDA rejected the label expansion. And informed the company the FDA would require a CVOT (Clinical Outcomes trial) to substantiate that Lovaza's therapeutic benefit outweighed the risks..

As a further note FDA's action in reneging the ANCHOR SPA was based on on three CVOTs..THRIVE, AIM HIGH and ACCORD. All of which were about trig lowering. The results of these three CVOTs Convinced the FDA that Vascepa's therapeutic benefits were not in the least bit OBVIOUS. Quite the opposite..And certainly the FDA knew about MORI...A "hypothesis generating" non peer reviewed paper published in an Australian nutritional journal..Right next to an article explaining what a "vegetable" was..(I can't make this stuff up).

":>) JL