Amarin Corp Plc (AMRN)

[Atom0aks]

Atom--ezetimibe DIDN'T have the endorsements and its drug incorporated in the guidelines of all medical WHEN it received a crl. Vascepa--has endorsements and guidelines of ALL medical org.

NOW YOU SEE THE DIFFERENCE? an endorsement of the ada/aha AFTER fda crl could not help it in the fda initial evaluation.

And I'm saying when a drug is endorsed does not matter. A drug can still be prescribed off label. See ADA on ezetimibe. It is still in the current (2019) guidelines for cardiovascular disease even though it does not have a label for it:

10.24 For patients with diabetes and atherosclerotic cardiovascular disease, if LDL cholesterol is ≥70 mg/dL on maximally tolerated statin dose, consider adding additional LDL-lowering therapy (such as ezetimibe or PCSK9 inhibitor). A Ezetimibe may be preferred due to lower cost.

In other words, doctors can prescribe vascepa for primary prevention of cardiovascular disease off-label because it is within guidelines. Amarin, however, wants the label.