Amarin Corp Plc (AMRN)

[HDGabor]

(Relevant) Events:

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

May
- May 19: Amicus curiae… if any

June
- June 22: Defendants-Appellees’ Responsive Brief (40 days from service of opening brief))

July
- July 2 : Plaintiffs-Appellants’ Reply Brief (assuming expedited filing …normal: July 13)
- 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.)

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

September
- Week 36 (August 31- September 4): Oral argument (FCA) …Meanwhile July / August is technically possible but it is not likely, September is the earliest, realistic time in any scenario 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)

November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: 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 (FCA) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval

February
- Healthcare professional and consumer launch: Delayed until after sales representatives can resume face-to-face meetings and pending successful ANDA appeal

April
- April 5: 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.:

(i) alternative EMA timetable, calculated by the 2-months reply

- May 22: Response to Day 120 list of questions (LoQ), March 26
- July 23: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- September 28: Commission Decision / formal approval (based on Day 180 Opinion by EMA, July 23)
- September 15: Response to Day 180 LoOI, July 23
- October 15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, October 15)

(ii) appeal: The Life of an Appeal