Amarin Corp Plc (AMRN)

[HDGabor]

B-

Sounds like an Adcom, then FDA approval process?

Yes ... and no.

- EMA is a mandatory "AdCom" in ever cases
- EU Commission does not make an own analysis like the FDA

Meanwhile the EMA Opinion is not binding for the Commission (like AdCom - FDA), the Commission never rejected, denied an application that got recommendation for approval from the EMA ... and never approved an application that was not recommended by the EMA.

It (approval by the EU Commission) is just a paper work ... they are following the EMA recommendation in every cases.

Best,
G