Amarin Corp Plc (AMRN)

[HDGabor]

C-

Can anything in your opinion change this or cause Amarin to push off this estimated timeline?

If somebody interested in Amarin as a "full/clean" BO. I mean: do not want to buy as BO Row + CVR for US or licensing EU with an option for a BO or would like to know the outcome of the trial

At this stage is it possible for them to push off EU decision until after court verdict?

The usual deadline (to answer letter from EMA) is 3 months and the June agenda does not include an topic regarding Vascepa (they did not request extension of time). It suggest that "Amarin not slow playing the EU", however:
- Amarin could not be sure that Day 180 (September) will be an Opinion and will not be a List of Outstanding Issue (LoOI)
- If it will be a LoOI, the Opinion (Day 210) could come by November as earliest (reply within a month) or by January 2021 (reply with standard 3 months) ... Approval in February and April 2021 respectively
- If it is "necessary" they could request extension of time - 3 months - at this stage, the Opinion (Day 210) will come by January and approval by March 2021

Scenario (not all):
(assuming September OA @ CAFC and Order by December and dates are EU approval)

(i) Day 180 is an Opinion, November 2020 ... 1 month "loss"
(ii) Day 180 is a LoOI, January 2021 (as earliest)

Furthermore, a "special" Phase 3 (at EMA) exist. If Day 180 will be a LoOI (it could be by EMA but could be triggered by Amarin reply intentionally by Amarin), Amarin could give a quick answer and the clock will running again within a days / weeks.

Amarin will know the OA schedule before they will know the content of the Day 2010 determination (Opinion or LoOI).

According to July IP "decision targeted for Q3 2020" ... I read it as: If all factor will be known we will decide in Q3 but if not it will be later.

They will move based on:
(a) Day 180 determination
(b) type of interest from potential partner and / or buyer (if any)

If I were ... I would give a Day 120 answer that trigger (with 100% certainty) the Day 180 LoOI.

Best,
G