Amarin Corp Plc (AMRN)

[HDGabor]

N-

If we can slow down

They could:

(i) request extension time (reply to Day 120 / March letter). If it is the case, we will know by end of June.
(ii) give a reply (to Day 120 / March letter) that will trigger Phase 3 (List of Outstanding Issues) with 100% certainty
(iii) request extension time (List of Outstanding Issues).

Earliest approval (assuming reply to Day 120 / March letter before end of May):
- recommendation by EMA: end of July (no Phase 3)
- approval by EU: early October

Latest approval (assuming (i) - (iii) above):
- recommendation by EMA: June 2021
- approval by EU: early August 2021

The difference is 10 months between the two ... but it does not effect the exclusivity period (min 10 yrs) just the period protected by the patent.

The period protected by the patent (with 10 yrs exclusivity):
- approval in October 2020: 36 months (till October 2033*)
- approval in August 2021: 26 months (till October 2033*)
* please note: I did not check the exact month of the patents but it is sometimes in 2033

The delay could have an additional advantage: less likely that generics will challenge the patents for 26 months gain than for 36 month gain

Best,
G