Tuesday, December 24, 2019 11:51:13 AM
Inflection point for determining EU strategy
JT has commented a few times that the company has not yet been forced to make a decision on partnering in EU. But now that the EU marketing application has been submitted, the clock is ticking IMO.
So two questions:
1) A partner or buyout is needed to commercialize V in EU. GIA is not an option. So does anyone have any thoughts on a possible time frame where/when a decision would need to be made? I’m thinking within next 3-6 months, but that’s just a guess.
2) Did Amarin intentionally delay the EU submission by 9 months in order to buy more time/defer this decision? In the meantime they also gained FDA approval, which essentially derisks the EU submission, as EU will most certainly follow FDA’s lead and approve V.
Would be curious to hear others thoughts. Happy holidays everyone.
-BS/OY
JT has commented a few times that the company has not yet been forced to make a decision on partnering in EU. But now that the EU marketing application has been submitted, the clock is ticking IMO.
So two questions:
1) A partner or buyout is needed to commercialize V in EU. GIA is not an option. So does anyone have any thoughts on a possible time frame where/when a decision would need to be made? I’m thinking within next 3-6 months, but that’s just a guess.
2) Did Amarin intentionally delay the EU submission by 9 months in order to buy more time/defer this decision? In the meantime they also gained FDA approval, which essentially derisks the EU submission, as EU will most certainly follow FDA’s lead and approve V.
Would be curious to hear others thoughts. Happy holidays everyone.
-BS/OY
Recent AMRN News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 08:30:11 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 03/30/2026 09:57:06 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/27/2026 09:00:07 PM
- Amarin Highlights Guideline Recommended Role of Icosapent Ethyl in Managing Cardiovascular Risk Following Release of Updated 2026 ACC/AHA/Multisociety Dyslipidemia Guideline • GlobeNewswire Inc. • 03/18/2026 12:30:00 PM
- New REDUCE-IT Data in Patients at Extreme Cardiovascular Risk and In Vitro Research on the Mechanistic Effects of Eicosapentaenoic Acid (EPA) on Lipoprotein(a) [Lp(a)] Oxidation to be Presented at the American College of Cardiology’s (ACC) Annual Scienti • GlobeNewswire Inc. • 03/16/2026 12:15:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/02/2026 10:31:01 PM
- Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT® Post Hoc Analysis Published in the European Journal of Preventive Cardiology • GlobeNewswire Inc. • 03/02/2026 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 12:05:26 PM
- Amarin Reports Fourth Quarter and Full Year 2025 Financial Results • GlobeNewswire Inc. • 02/25/2026 12:00:00 PM
- This American Heart Month Amarin Spotlights the Need to Prioritize Proven Widely Available Yet Underutilized Therapies in the Battle Against Cardiovascular Disease • GlobeNewswire Inc. • 02/23/2026 01:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on February 25, 2026 • GlobeNewswire Inc. • 02/11/2026 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:06 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:05 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:04 AM
- Amarin Applauds Breakthroughs In Therapies For Patients With Elevated Triglycerides; Company’s VASCEPA®/VAZKEPA® (Icosapent Ethyl) Franchise Well Positioned To Benefit Globally From Broadened Category Commercialization • GlobeNewswire Inc. • 01/09/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2026 12:05:27 PM
- Amarin Announces Preliminary 2025 Financial Highlights and Operational Accomplishments, Including Achieving Positive Cash Flow; Company Well Positioned to Capture Global Growth Opportunities • GlobeNewswire Inc. • 01/08/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:10 PM
- New REDUCE-IT® Aspirin Analysis Presented at AHA Scientific Sessions 2025 Reinforces VASCEPA®/VAZKEPA® (Icosapent Ethyl) Reduced Cardiovascular Events in High-Risk Patients • GlobeNewswire Inc. • 11/09/2025 09:15:00 PM
- Amarin To Present New Analyses Affirming Robustness of Data from REDUCE-IT and Additional Mechanisms of Action of Eicosapentaenoic Acid (EPA) at American Heart Association (AHA) Scientific Sessions 2025 • GlobeNewswire Inc. • 11/03/2025 01:30:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 10/31/2025 08:30:06 PM
