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Thursday, September 11, 2014 2:05:29 PM
It took the FDA, what, 18 months to inform AMRN of the NCE NO decision. During that time, the spin was that "why would the FDA wait so long just to deny NCE..." Remember? So anyone who believes that the SPA decision "delay" has anything to do with increasing the odds that an approval is in the companies grasp is, again, mistaken. It sure feels like the MPC advice will confirm the FDA's previous decisions, and the decision will be an even stronger "no" considering it will not just come from the office of JJ. So NCE lawsuit, then 1st Amendment rights in court, followed by a lawsuit over the SPA (likely). I'm sure all these event's will have no affect on the overall relationship between the FDA and AMRN when it comes to R-It now, right?
On a side note, how long would it take to secure a 1st amendment judgment? Remember the outrage and how easy we all thought it was going to be for the management bonuses before the end of 2014? They even had to change the date from mid 2014 to end of 2014, now it is possible that they might run out of time and get NOTHING before end of year. The incompetence here never ends...
It seems that some of the hot money (small amount) is exiting based upon the realization from yesterday that there is no comprehensive discussions going on with the FDA. This is going to be a black or white decision, followed by lawsuits.
Recent AMRN News
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- 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
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- 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
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- 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
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
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- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
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