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Proxy Statement (definitive) (def 14a) Edgar (US Regulatory) - 6/1/2020 4:15:58 PM
Amarin Plans to Increase VASCEPA® (icosapent ethyl) Promotion and Education GlobeNewswire Inc. - 6/1/2020 7:00:10 AM
Amarin Supports Trial to Investigate the Effects of VASCEPA® (icosapent ethyl) in the Treatment of COVID-19 GlobeNewswire Inc. - 5/21/2020 4:05:10 PM
VASCEPA® (icosapent ethyl) Shows Significant Reduction in Coronary Revascularization, Including Coronary Stenting and Cardia... GlobeNewswire Inc. - 5/14/2020 2:50:10 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/8/2020 5:19:58 PM
Quarterly Report (10-q) Edgar (US Regulatory) - 4/30/2020 6:39:17 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 4/30/2020 6:32:26 AM
Amarin Reports First Quarter 2020 Financial Results and Provides Update on Operations GlobeNewswire Inc. - 4/30/2020 5:00:10 AM
Amended Annual Report (10-k/a) Edgar (US Regulatory) - 4/29/2020 4:12:49 PM
Amarin to Report First Quarter 2020 Results and Host Conference Call on April 30, 2020 GlobeNewswire Inc. - 4/28/2020 7:00:10 AM
Cannabis? CBD? That's Old News, A New Sector Bull Run Has Begun InvestorsHub NewsWire - 4/16/2020 8:00:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 4/13/2020 4:37:32 PM
Amarin to Host Conference Call on April 13, 2020 to Provide Preliminary First Quarter 2020 Results and Operational Update GlobeNewswire Inc. - 4/8/2020 4:05:10 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 3/31/2020 9:23:01 AM
Amarin Highlights VASCEPA® (Icosapent Ethyl)-Related Data Presented at American College of Cardiology’s Annual Scientific ... GlobeNewswire Inc. - 3/31/2020 7:00:10 AM
Amarin Comments on Ruling in VASCEPA® ANDA Litigation GlobeNewswire Inc. - 3/30/2020 6:25:32 PM
Eicosapentaenoic Acid (EPA) Levels From VASCEPA® (Icosapent Ethyl) in REDUCE-IT® Strongly Correlated with Cardiovascular Ou... GlobeNewswire Inc. - 3/30/2020 11:45:10 AM
Pharmaceutical Firms Curtailing In-Person Sales Calls to Doctors Dow Jones News - 3/16/2020 2:29:00 PM
Eight Data Presentations Relevant to VASCEPA® (Icosapent Ethyl) Capsules and Persistent Cardiovascular Risk to be Presented ... GlobeNewswire Inc. - 3/16/2020 8:00:10 AM
Amarin Takes Proactive Steps to Support Public Health Priorities GlobeNewswire Inc. - 3/15/2020 1:56:22 PM
Automatic Shelf Registration Statement of Securities of Well-known Seasoned Issuers (s-3asr) Edgar (US Regulatory) - 2/26/2020 5:24:33 PM
ALYI Trending VERY BULLISH at $0.004 with 1000% ROI Potential InvestorsHub NewsWire - 2/26/2020 8:58:36 AM
Annual Report (10-k) Edgar (US Regulatory) - 2/25/2020 4:11:55 PM
HDGabor   Friday, 05/15/20 06:00:39 PM
Re: Dancing in the dark post# 271044
Post # of 277701 
(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



Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.
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