Amarin Corp Plc (AMRN)

[HDGabor]

I also think there is a substantial chance they will reinstate the SPA at this level in the near future.. but hopefully in this month, during next (2) week(s).

I do not think that they will modify anything the SPA (it does not have any rationale). Based on the reinstated SPA they will (have to) approve ANCHOR indication as it is:

VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
CHD risk equivalents comprise:
- Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
- Diabetes;
- Multiple risk factors that confer a 10-year risk for CHD > 20%.

Limitation of Use will be on the label as:
- The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
- The effect of VASCEPA on cardiovascular mortality and morbidity in patients has not been determined.

If they would like some face saving modification they can do it on the label only (ie.: the exact wording of the indication, “highlight” the Limitation of Use, within the rest of the label)