Replies to post #287339 on Amarin Corp Plc (AMRN)

[HDGabor]

(Relevant) Events:

Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.

August
- Week 32: Q2 2020 (10-Q and CC)

September
- September 2, 10:00 a.m: Oral argument (CAFC)
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)

October
- October 5: Preliminary Q3 (TBC)

November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)

December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result

January
- Order (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval

April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)

Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company:
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) *clock restart
d.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter

Best,
G

ps.:

(i) “shortest” EMA timetable in case of LoOI

- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

(ii) “longest” EMA timetable

- September 14-17: Day 180 LoOI
- December 7-10: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI,
- March 23*: Response to Day 180 LoOI, September 17
- April 19-22: Day 210 Opinion by EMA / recommendation of approval
- June 28: Commission Decision / formal approval (based on Day 210 Opinion by EMA, April 22)