Sunday, February 26, 2017 1:32:52 PM
international distribution is a revenue, isn't a cost
Eventually, yes - but first they have to go to the expense of getting ROW approvals for V - hopefully by signing up partners like Eddingham that will pick up all costs plus provide some upfront money. I own several other bios that "went it alone" in gaining or trying to gain drug approvals from the EMA, Canada, and Mexico. EMA process can take several years, it's quite different that FDA process, which I'm sure you know, but others may not.
As far as any continuation studies after R-IT is halted, I could see value in following patients for years, but don't know if AMRN would be willing to continue to supply V for free plus pay for checkups, i.e. continue as an open label trial for some amount of time - I can see arguments for and against that. Also, we've seen some recent articles on follow-up studies done many years after the original trial ended (the niacin raised CV risk for women by 30% one?) - but I don't know if drug companies pay for that research or if universities and/or NIH provide funding for that type of thing, probably varies, a mix of both. If not funded by AMRN, there's no guarantee that anybody would be willing or want to do that sort of long term follow-up study, but if R-IT is a smashing success I'd guess it would generate plenty of interest in doing it, would provide a variety of thesis ideas for those seeking PhD's.
Eventually, yes - but first they have to go to the expense of getting ROW approvals for V - hopefully by signing up partners like Eddingham that will pick up all costs plus provide some upfront money. I own several other bios that "went it alone" in gaining or trying to gain drug approvals from the EMA, Canada, and Mexico. EMA process can take several years, it's quite different that FDA process, which I'm sure you know, but others may not.
As far as any continuation studies after R-IT is halted, I could see value in following patients for years, but don't know if AMRN would be willing to continue to supply V for free plus pay for checkups, i.e. continue as an open label trial for some amount of time - I can see arguments for and against that. Also, we've seen some recent articles on follow-up studies done many years after the original trial ended (the niacin raised CV risk for women by 30% one?) - but I don't know if drug companies pay for that research or if universities and/or NIH provide funding for that type of thing, probably varies, a mix of both. If not funded by AMRN, there's no guarantee that anybody would be willing or want to do that sort of long term follow-up study, but if R-IT is a smashing success I'd guess it would generate plenty of interest in doing it, would provide a variety of thesis ideas for those seeking PhD's.
The Thought Police: To censor and protect. Craig Bruce
Recent AMRN News
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 04/10/2026 09:01:34 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 04/10/2026 09:00:20 PM
- American College of Cardiology (ACC) Scientific Sessions 2026 Underscore the Need for Complementary Therapies Including Icosapent Ethyl (IPE) in Treatment of Elevated Triglycerides and Cardiovascular Risk Reduction • GlobeNewswire Inc. • 04/08/2026 12:00:00 PM
- 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
