Replies to post #332004 on Amarin Corp Plc (AMRN)

[HDGabor]

Before Amarin PR's the European approval, the content/scope of the indication/label is probably in mind also. Negotiation in progress?

Negotiation after approval? Wow ... Furthermore, the full indication is:

Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and

established cardiovascular disease, or
diabetes, and at least one other cardiovascular risk factor.

[Freifaller]

Nope- The only thing EC and EMA doing is to clarify the wording of the label and then all member states of the EU have to translate it in their native language.

EU consists of many countries with different languages. That´s the point, why it takes time.