Home > Boards > US Listed > Biotechs > Amarin Corp. PLC ADS (AMRN)

Regarding Vascepa sNDA REDUCE-IT indication:

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (2) | Next 10 | Previous | Next
Biobillionair Member Profile
 
Followed By 105
Posts 15,417
Boards Moderated 0
Alias Born 01/12/13
160x600 placeholder
Current Report Filing (8-k) Edgar (US Regulatory) - 5/23/2019 5:02:53 PM
Vascepa® to Be Featured in Multiple Scientific Sessions at the National Lipid Association Annual Meeting GlobeNewswire Inc. - 5/16/2019 4:15:00 PM
Quarterly Report (10-q) Edgar (US Regulatory) - 5/1/2019 6:50:57 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 5/1/2019 6:49:35 AM
Amarin Reports First Quarter 2019 Financial Results and Provides Update on Operations GlobeNewswire Inc. - 5/1/2019 5:00:00 AM
New Drug Submission Filed for Vascepa® with Health Canada GlobeNewswire Inc. - 4/29/2019 6:00:00 AM
Proxy Statement (definitive) (def 14a) Edgar (US Regulatory) - 4/25/2019 7:02:14 AM
Amarin To Report First Quarter 2019 Results and Host Conference Call On May 1, 2019 GlobeNewswire Inc. - 4/24/2019 6:00:00 AM
Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) Edgar (US Regulatory) - 4/15/2019 5:08:09 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 4/1/2019 5:09:07 PM
Vascepa® Granted Priority Review Status from Health Canada GlobeNewswire Inc. - 3/29/2019 5:45:15 PM
Amarin Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for Vascepa® (icosapent ethyl) t... GlobeNewswire Inc. - 3/28/2019 4:51:57 PM
New Updates to the American Diabetes Association’s® 2019 Standards of Medical Care in Diabetes Incorporate Findings from t... GlobeNewswire Inc. - 3/28/2019 5:00:00 AM
Cardiovascular Risk at Multiple Triglyceride Thresholds Highlighted in Presentation at American College of Cardiology’s 68... GlobeNewswire Inc. - 3/19/2019 6:00:00 AM
Additional Real-World Data Show a Significant Risk Increase in Cardiovascular Events in People with Elevated Triglyceride Lev... GlobeNewswire Inc. - 3/18/2019 4:15:00 PM
Vascepa® (icosapent ethyl) Showed 30% Reduction in Total Cardiovascular Events Including Recurrent Events in REDUCE-IT™ PR Newswire (US) - 3/18/2019 9:00:00 AM
High Risk of Atherosclerotic Cardiovascular Events Projected in People with Elevated Triglycerides Without Established Athero... GlobeNewswire Inc. - 3/16/2019 5:30:00 PM
Investor Expectations to Drive Momentum within Amarin, PulteGroup, LivaNova, Teva Pharmaceutical Industries, Viad, and Activi... GlobeNewswire Inc. - 3/6/2019 8:25:00 AM
Amarin to Present at Cowen’s 39th Annual Health Care Conference GlobeNewswire Inc. - 3/5/2019 6:00:00 AM
Important New Data on Vascepa® (Icosapent Ethyl) from the REDUCE-IT™ Trial to Be Presented Regarding Reduction in Total Is... GlobeNewswire Inc. - 3/4/2019 4:30:00 PM
Gibbs Law Group Has Filed Sole Class Action; Shareholders Should Contact the Firm About Their Rights Business Wire - 3/1/2019 5:00:00 PM
The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Amarin Corp. plc & En... Business Wire - 2/27/2019 2:25:00 PM
Annual Report (10-k) Edgar (US Regulatory) - 2/27/2019 6:39:33 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 2/27/2019 6:31:09 AM
Amarin Reports Record Fourth Quarter and Full Year 2018 Financial Results and Provides Update on Operations GlobeNewswire Inc. - 2/27/2019 5:00:00 AM
Biobillionair   Tuesday, 02/12/19 08:32:12 AM
Re: None
Post # of 193538 
Regarding Vascepa sNDA REDUCE-IT indication:

The "delay" in filing the sNDA is on the FDA for not addressing the DS Omega industry at the time of Amarin's ITC case filing.

What's taking the Federal Circuit Court so long? Reading the history between Amarin and the FDA is a formidable task; after which the Court must render a just opinion. There is no way to frame a just opinion without the complete unraveling of the abuse of power directed at Amarin, Vascepa, and stakeholders.

I think it's vital for the FDA to paint themselves in the best light prior to the ITC coming forward with a just opinion regarding the FDA's choice of NOT following Code of Federal Regulations and controlling the supplement industry. Further, the involvement of Congressional meddling in the case likely warrants an independent HHS OIG investigation of Congressman Frank Pallone.

I'm not sure when we see the ITC ruling, but my gut tells me it's not going to favor two Agencies that refused to do their respective jobs. This is LITERALLY a breach of Constitutional "Due Process". The ITC case IMO opens a damages phase which at this point the FDA can't avoid. I think this phase will be organized and quiet with Amarin being justly awarded future drug accelerated program certificates...think AMR 103 drug development program.

BB

I do not pump Amarin stock. I am not an Amarin cheerleader. If I see something I don't like I make it known. Patients come first, always!!!
Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (2) | Next 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist