Amarin Corp Plc (AMRN)

[HDGabor]

z-

The FDA approved the Marine study for Vascepa's trig lowering effect on LDL in patients with VERY HIGH TRIGS in 2012

The FDA approved Vascepa in TG >500 based on TG lowering effect … effect on LDL was not an aspect, did not matter (e.g. Lovaza was approved despite LDL increase)

FDA still didn't believe that Trigs could be lowered without raising LDL in high or...especially very high LDL patients(i.e. the Marine group)...and they felt that increased LDL would lead to more CVD... This is the reason why the FDA refused to approve Vascepa for the Anchor designation

The FDA did not say anything about LDL during the ANCHOR "investigation" … The reason - why the FDA refused to approve Vascepa for the Anchor designation - was that the FDA - correctly - did not believe (was not convinced) that lipid modification (TG or LDL or any other … aka laboratory outcome) will decrease CVE. They would like to see the clinical outcome.

SMH … ANDAs first, this one as second … Unless you think everybody are a newbie or have a short memory I do not have any idea why do you post these …

Best,
G