Friday, July 19, 2013 4:28:27 PM
My only guess is since NCE is supposed to require an Adcom and there was not one. I think originally the lawsuits over NCE created new guidelines which were not approved until May 2013 and AMRN is the first major drug caught up in NCE decision and with Anchor Adcom FDA probably said, let's wait until Adcom and discuss at Adcom.
Will be interested to see if Adcom mention NCE at all. If not then maybe they want Anchor approval to use as backup when GSK says Lovaza has same active ingredient and they can say, well if it did, it would have had same effect in Anchor population but you are not approved for that an they are.
Otherwise, no idea.
Recent AMRN News
- Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual • GlobeNewswire Inc. • 11/11/2024 01:00:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 10/31/2024 08:42:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 10/30/2024 08:10:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2024 08:10:08 PM
- Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 10/30/2024 08:05:00 PM
- Amarin Announces Two Upcoming Investor Events • GlobeNewswire Inc. • 10/01/2024 12:00:00 PM
- Research Highlighting the Clinical Impact of VASCEPA®/VAZKEPA (icosapent ethyl) in Patients with Diabetes and High Cardiovascular Risk and the Anti-Lp(a) Oxidation Mechanistic Effect of Eicosapentaenoic Acid (EPA) to be Presented at the 60th Annual Europe • GlobeNewswire Inc. • 09/09/2024 11:30:00 AM
- Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress • GlobeNewswire Inc. • 08/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 09:30:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
Alliance Creative Group (ACGX) Releases Q3 2024 Financial and Disclosure Report with an increase of over 100% in Net Income for 1st 9 months of 2024 vs 2023 • ACGX • Nov 14, 2024 8:30 AM
Unitronix Corp. Publishes Its Cryptocurrency Portfolio Strategy • UTRX • Nov 14, 2024 8:05 AM
Avant Technologies and Ainnova Tech Form Joint Venture to Advance Early Disease Detection Using Artificial Intelligence • AVAI • Nov 12, 2024 9:00 AM
Swifty Global Announces Launch of Swifty Sports IE, Expanding Sports Betting and Casino Services in the Irish Market • DRCR • Nov 12, 2024 9:00 AM
Oohvie App Update Enhances Women's Health with Telemedicine and Online Scheduling • HLYK • Nov 11, 2024 8:00 AM
SANUWAVE Announces Record Quarterly Revenues: Q3 FY2024 Financial Results • SNWV • Nov 8, 2024 7:07 AM