Amarin Corp Plc (AMRN)

[HDGabor]

(Relevant) Events:

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

June
- June 26 : Plaintiffs-Appellants’ Reply Brief (CAFC)

July
- July 1: Joint appendix (CAFC)
- July 6: Preliminary Q2 (TBC)
- July 17*: Response to Day 120 list of questions (LoQ), March 26 (Please note: all EMA deadlines – below – are based on response by July 17. Amarin has three months to answer the LoQ but the no clock restart in June … *clock restart)
- Healthcare professional and consumer launch

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

September
- Week 36 (August 31- September 4): Oral argument (CAFC) …Meanwhile August is technically possible it is not likely, September is the earliest, realistic time but could be later
- September 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.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter

Best,
G

ps.: alternative (“longest”) EMA timetable

- June 25: CHMP meeting, Request extension of time (+3-months) for response to Day 120 LoQ, March 26
- October 9*: Response to Day 120 list of questions (LoQ), March 26
- December 10: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- February 15: Commission Decision / formal approval (based on Day 180 Opinion by EMA, December 10)
- March 25: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI, December 10
- June 22*: Response to Day 180 LoOI, December 10
- July 22: Day 210 Opinion by EMA / recommendation of approval
- September 27: Commission Decision / formal approval (based on Day 210 Opinion by EMA, July 22)