Amarin Corp Plc (AMRN)

[OldYeller187]

Yes, definitely conceivable Amarin could know of EU Accelerated Approval ahead of the FDA decision on the same (ie Priority Review).

And you’re correct, request for AA and presubmission meetings around the same happen months in advance of the EU submission. But unfortunately we are in the dark on this - and IR is staying mum on it. I have already tried asking everal times :(

Edit: Just realized I didn’t completely answer your entire question. If granted AA in EU, but only standard in US, the expanded label come potentially come in EU first. The regulatory process in EU is a bit more complex than US, so I’d have to look closer at the exact timetable. That said, I don’t think this scenario is likely. I think we have better chance of getting an expedited review in US than EU. It’s typically much more difficult to receive in EU.