Wednesday, August 14, 2019 3:58:16 PM
JL, your response is exactly why I have been so bewildered at all the rapidly changing speculation about what is going on.
I agree that had there been a label change, shareholders should have been notified; however, I may be wrong. We don't know what was on the first label request so we would not likely have been told what might have been in a second label request for likely the same reasons we don't know what's in the first. Based on that logic, it is reasonable to think that there would have been no duty to disclose a new label request to shareholders. If there had been a duty to disclose it, you can pretty much rest assured that the BOD and their advisors would have discussed disclosure and would have done the right thing. Failure to disclose can have massive negative implications (as you well know) and I just don't buy that management would not have known it needed to be disclosed; hence... there was no second label request
Nevertheless, JT stated in the 8/8 call that the PDUFA date would be December. Why? Because the AdCom is more likely than not about the first and only label requested by Amarin and, as a result of the AdCom, the PDUFA date would HAVE to be moved because they're certainly not going to grant a label change and THEN do an AdCom.
Everyone is making stuff up like mad.
Based on what we actually know (not what everyone is making up), it is far more reasonable to expect the PDUFA date will be delayed to some point after the AdCom.
I agree that had there been a label change, shareholders should have been notified; however, I may be wrong. We don't know what was on the first label request so we would not likely have been told what might have been in a second label request for likely the same reasons we don't know what's in the first. Based on that logic, it is reasonable to think that there would have been no duty to disclose a new label request to shareholders. If there had been a duty to disclose it, you can pretty much rest assured that the BOD and their advisors would have discussed disclosure and would have done the right thing. Failure to disclose can have massive negative implications (as you well know) and I just don't buy that management would not have known it needed to be disclosed; hence... there was no second label request
Nevertheless, JT stated in the 8/8 call that the PDUFA date would be December. Why? Because the AdCom is more likely than not about the first and only label requested by Amarin and, as a result of the AdCom, the PDUFA date would HAVE to be moved because they're certainly not going to grant a label change and THEN do an AdCom.
Everyone is making stuff up like mad.
Based on what we actually know (not what everyone is making up), it is far more reasonable to expect the PDUFA date will be delayed to some point after the AdCom.
Recent AMRN News
- Amarin Highlights New REDUCE-IT Analysis Showing Risk-Weighted ApoB May Improve Cardiovascular Risk Detection (AMRN) • IH Market News • 05/27/2026 03:24:38 PM
- New REDUCE-IT® Analysis Presented at the European Atherosclerosis Society (EAS) Congress 2026 Suggests Risk-Weighted ApoB May Improve Identification of Residual Cardiovascular Risk in Statin-Treated Patients with Hypertriglyceridemia • GlobeNewswire Inc. • 05/27/2026 12:00:00 PM
- Earnings Report Shows Narrowing Losses as Amarin (AMRN) Advances Partner-Led Growth Strategy • IH Market News • 04/29/2026 02:19:17 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 04/29/2026 11:06:34 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/29/2026 11:05:15 AM
- Amarin Reports 2026 First Quarter Financial Results • GlobeNewswire Inc. • 04/29/2026 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/22/2026 09:00:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:02 PM
- Amarin to Report First Quarter 2026 Financial Results and Host Conference Call on April 29, 2026 • GlobeNewswire Inc. • 04/15/2026 12:00:00 PM
- 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
