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Amarin Q4 results led by strong Vascepa sales Seeking Alpha - 2/25/2021 9:48:43 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 2/25/2021 6:07:01 AM
Amarin EPS beats by $0.04, beats on revenue Seeking Alpha - 2/25/2021 5:58:27 AM
Amarin Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update GlobeNewswire Inc. - 2/25/2021 5:55:00 AM
Amarin Q4 2020 Earnings Preview Seeking Alpha - 2/24/2021 11:55:46 AM
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Amarin to Present at Two Upcoming Investor Conferences GlobeNewswire Inc. - 2/18/2021 6:05:00 AM
Amarin to Report Fourth Quarter and Full Year 2020 Results and Host Conference Call on February 25, 2021 GlobeNewswire Inc. - 2/17/2021 8:05:00 AM
Nextech AR (OTCQB: NEXCF) 2021 Guidance $50-60 Million Closes 2020 with $20 million. InvestorsHub NewsWire - 2/12/2021 6:26:34 AM
Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong GlobeNewswire Inc. - 2/9/2021 7:00:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 1/29/2021 5:01:28 PM
Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction GlobeNewswire Inc. - 1/29/2021 12:51:51 PM
VASCEPA® (Icosapent Ethyl) Receives Further Inclusions in Guidelines from International Medical Societies for its Role in Re... PR Newswire (Canada) - 1/28/2021 6:30:00 AM
Amarin Expands Cardiovascular Risk Reduction Patent Infringement Lawsuit to Include Health Care Insurance Provider GlobeNewswire Inc. - 1/25/2021 7:35:00 PM
Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascul... GlobeNewswire Inc. - 1/21/2021 4:30:00 PM
The FDA Calendar Review Dates Can Play a Big Role in Timing Your Trades, But Not the Way You May Think InvestorsHub NewsWire - 1/7/2021 8:00:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 1/7/2021 6:16:40 AM
Amarin Provides Preliminary 2020 Results and 2021 Outlook GlobeNewswire Inc. - 1/7/2021 6:05:00 AM
Amarin to Present at 39th Annual J.P. Morgan Healthcare Conference GlobeNewswire Inc. - 1/4/2021 6:05:00 AM
Amarin Highlights Multiple VASCEPA® (Icosapent Ethyl)-Related Scientific Findings Presented at National Lipid Association (N... GlobeNewswire Inc. - 12/14/2020 5:00:00 AM
Amarin Reports Encouraging Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with VASCEPA®... GlobeNewswire Inc. - 12/12/2020 9:30:00 PM
VASCEPA® (Icosapent Ethyl)-Related Scientific Findings to Be Presented at National Lipid Association (NLA) Scientific Sessio... GlobeNewswire Inc. - 12/7/2020 7:00:00 AM
Amarin Files Patent Infringement Lawsuit Against Hikma GlobeNewswire Inc. - 11/30/2020 7:54:44 PM
Amarin to Present at Piper Sandler’s 32nd Annual Healthcare Conference (Virtual) GlobeNewswire Inc. - 11/24/2020 6:05:00 AM
Amarin Shares Topline Data from Partner’s Pivotal Phase 3 Study of VASCEPA® (Icosapent Ethyl) in Mainland China GlobeNewswire Inc. - 11/19/2020 6:30:00 PM
HDGabor   Monday, 09/14/20 06:53:09 AM
Re: Dancing in the dark post# 298752
Post # of 328193 
(Relevant) Events:

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

(i) “standard” EMA timetable

- September 17: List of Outstanding Issues (LoOI)
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- January 28: Day 210 Opinion by EMA / recommendation of approval
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)

(ii) “shortest” EMA timetable (after clock-stop for responses)

- September 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 18: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

(iii) “shortest” EMA timetable (after immediate responses**)

- September 17: Day 180 List of Outstanding Issues (LoOI)
- September 22*: Response to Day 180 LoOI, September 17
- October (12-)15: Day 210 Opinion by EMA / recommendation of approval
- December 21: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)

*clock restart
** This timetable is only used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.

Best,
G

Notice: This post will not be updated anymore.

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