Amarin Corp Plc (AMRN)

[jessellivermore]

HK...

This is probably the most important determinate of why Du was so wrong..In 2012 when ANCHOR was completed..Virtully everyone in the lipology field held tht trig lowering ALWAYS resulted in the LDL-C levels increasing..Here to fore Trigs had been considered a risk factor for CVD events.

http://epadruginitiative.com/press/fda-puts-patients-at-risk

FDA convened an Adcom which met on Oct 13 1013..The independent panel voted on the now famous Mary Parks question..The question asked was considering the ANCHOR trial results (in light of three other trig lowering trials [Thrive, ACCORD, and AIM-HIGH]..none of which showed convincing evidence that trig lowering lowered CVD event risk) were they the panelist confident Vascepa in the suggested dose lower CVD event. The panel said no..The ANCHOR trial was not designed or powered to answer whether the drug would lower events or save lives inn those with CVD..The FDA continued in a full sweep to declare they no longer considered elevated trigs a risk factor..A position held by the AHA the ADA and the NIH..They followed shortly by reneging on the SPA they had granted Amarin..On the flimsy basis that new scientific evidence indicated EPA's ability to lower CVD event risk was unlikely..Central to FDA's turn about was that trig lowering did indeed raise LDL-C and FDA held that only LDL-C was a legit bio marker for CVD event risk..

Such were the events leading to the R-I CVOT..

It is inappropriate to consider points of view in clinical situations such as the therapeutic benefits of N-3s or "Fish Oil." By Picking out one study which supports ones point of view, where there are literally hundreds of other trials, studies or paper that do not agree. This is the very worst kind of kind of Cherry picking..And is "Fake Science" or "Judge Du Science"..That does not in anyway indicate the overall opinion of the Medical field..The truth is there was no consensuses.At the time of MORI. MORI was not a KOL..The issues were controversial and still were until a short time ago..Nothing that MORI said or did had any effect in the time and place where he said or did it..

The general view (the most agreed on) at that time would have been high Trigs are a risk factor for CVD but lowering trigs raised LDL-C and this was confirmed (expected) by the Friedwald Equation and the clinical specialists who treated Atherosclerosis. And the benefits of trig lowering were not great enough to defray the risks of raising the LDL-C..

":>) JL