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Friday, January 04, 2019 3:40:11 PM
duck manure.
I read an article in WAPO yesterday where a consultant was quoted as saying he's afraid of the backlog that FDA will have to push through whenever the shutdown is lifted. A quick search of the consultancies does show past experience, post-shutdowns with CDER-regulated products is to build the new backlog delay into a timeline. Should I assume then by the time AMRN is ready to file in 60ish days? that we can add another 3 weeks and counting to original forecasts for either an expedited or regular approval process due to the shutdown imposed backlog?
Meanwhile Scott Gottlieb is tweeting that he's not leaving the FDA.
My wild guess is that the shutdown is lifted by Sunday night.
Recent AMRN News
- 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
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
Nightfood Holdings Inc. Completes Major Step on Uplist Journey by Closing Strategic All-Stock Acquisition of CarryoutSupplies.com • NGTF • Sep 10, 2024 8:15 AM
Element79 Gold Corp. Announces Sale of 100% Interest in Elder Creek, North Mill Creek, and Elephant Projects to 1472886 B.C. Ltd. • ELEM • Sep 9, 2024 9:34 AM
North Bay Resources Commences Gold Shipments, Fran Gold Project, British Columbia; Enters Taber Gold Mine JV, Sierra County, California • NBRI • Sep 9, 2024 9:15 AM
Simple Stock Loans Announces Unique Solutions For Investors Looking for Alternative Liquidity Amidst Recent Small Cap Rally Sep 6, 2024 9:30 AM
Reliant Coffee Debuts at #271 on the Inc. 5000 List of Fastest Growing Companies - Coffee Service Industry Disruptor Brews Up Exponential Growth Sep 5, 2024 11:51 AM
VAYK Confirms Receiving Revenue from First Airbnb Property with 1.4 Million Annual Revenue Goal • VAYK • Sep 4, 2024 9:34 AM