Amarin Corp Plc (AMRN)

[HDGabor]

C-

What if decision is pushed back until after they receive Europe approval in November?

More likely the decision will come later than November (inc. expedited process … which - as I know - was not granted as of today).

You would think they (Amarin, partner or acquiring company) would want to hit the ground running in Europe to maximize sales and not jeopardize time.

Agree, however … see below.

Opposed to a CVR attached to a deal now so BP can be involved in the appeal?

I do not see any value in a "BP involved" … I am sure Jerry Fletcher(s) see it differently.

EU approval:
- November is a possible date as one of the earliest (the earliest is August / September)
- Amarin received the 120 day letter on or before March 26 … the usual timeframe is 3-months for the answer but no June clock restart exist … the next one is July 17
(a) Amarin could request extension of time … the due date could be later
(b) Amarin could give an answer that will trigger (with 100% possibility) a LoOI … a 3rd phase
- In case of 180 day letter (LoOI by end of September … if answer for 120-day letter will be filed before July 17) Amarin will have 3-months again to answer
- EMA final opinion will take a month … and approval will be an additional 2 months

All together: Amarin could delay the EMA approval till end of Q1 / mid Q2 … without losing exclusivity (and losing a few months of the patent protection after exclusivity)

Best,
G