Amarin Corp Plc (AMRN)

[HDGabor]

g- (Invest83838)

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.

- - - - -

HDG, so you believe EMA opinion means (always) 100% surety of EU/EC Decision?

Meanwhile the EMA Opinion is not binding for the EC* the surety of EU/EC decision is 99.999999999999%. The recommendation from the EMA’s CHMP still has to be approved by the European Commission, but CHMP opinions are routinely adopted.

I am aware one case only - Cell Therapies Research & Services, Orphacol (cholic acid), a drug intended for the treatment of inborn errors in primary bile acid synthesis - where the EC's decision to refuse approval to Orphacol came despite a recommendation from the EMA. But the European Court of Justice has instructed the EC to approve it.

I do not aware of any case for the opposite (negative EMA opinion but approved).

* Whether positive or negative, the CHMP opinion is communicated to the applicant and to the EC to issue a binding decision. The EC, before releasing the final decision, forwards a draft decision to a regulatory committee called the Standing Committee on Medicinal Products for Human Use where representatives of the MS have 30 days to raise objections. If important objections are raised, the CHMP is asked to formulate a reply, and a new Standing Committee procedure is started based on the CHMP answer.

Best,
G