Replies to post #237031 on Amarin Corp Plc (AMRN)

[HDGabor]

B-

V could be approved in the EU as:

- Q2/Q3 2020: Approval by EMA (if no question; by end of "Phase I") … could be but is not a most likely scenario
- Q3 2020: Approval by EMA (if no more question; by end of "Phase II") … about Sep / Oct
- Q4 2020: Approval by EMA (by end of "Phase III") … as the latest about November / end of November

Just a guess: but the "case" should be solved around May / June as the latest … to cover "Phase I" approval (as the latest) by end of March.

Best,
G

[sts66]

Agree a decision/deal to partner in EU needs to be done in the next 3-6 months else they risk getting EMA approval without a way to distribute V in the EU, wasting a precious period of exclusivity. I think they hold off on signing a partner until they see if an acceptable BO offer is made, likely once the current litigation is over and settled.

AMRN delayed the EU submission so they could devote all resources to gaining FDA approval for R-IT, it was by far the #1 priority - they're a small company, couldn't afford to spread themselves too thin - IMO it had nothing to do with any partnering discussions as they likely put those on hold as well. Delaying also allowed papers like the one posted here earlier to be published, greasing the wheels for V approval in the EU.

https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehz778/5686013