Tuesday, January 17, 2023 6:41:25 PM
Ram. this provides more detail
https://rethinkingclinicaltrials.org/news/june-18-2021-the-mitigate-study-insights-from-a-decentralized-virtual-electronic-health-record-based-pragmatic-clinical-trial-andrew-ambrosy-md-alan-go-md/
AMRN needs more clinical trial evidence ( as KM says Real World Evidence ) to raise their Level of Evidence rating ...currently at 11b ( 2 b ) for EU markets such as Germany and France that place a lot of weight on independent trials confirming the risk reduction of the pivotal trial ...R-IT
MITIGATE is the only trial AMRN is funding that can provide this additional CV data .
The CV data is exploratory endpoints and listed as such in clinical trials.gov.
These endpoint results will be followed ...and if they follow them long enough ( say 2 yrs for event lines to clearly diverge )..hopefully AMRN can use them to increase their Level of Evidence rating .
By the way ..from the Oct CC
Reimbursement decisions due from France , Italy and Spain by end of 2022 or early 2023
Kiwi
https://rethinkingclinicaltrials.org/news/june-18-2021-the-mitigate-study-insights-from-a-decentralized-virtual-electronic-health-record-based-pragmatic-clinical-trial-andrew-ambrosy-md-alan-go-md/
AMRN needs more clinical trial evidence ( as KM says Real World Evidence ) to raise their Level of Evidence rating ...currently at 11b ( 2 b ) for EU markets such as Germany and France that place a lot of weight on independent trials confirming the risk reduction of the pivotal trial ...R-IT
MITIGATE is the only trial AMRN is funding that can provide this additional CV data .
The CV data is exploratory endpoints and listed as such in clinical trials.gov.
These endpoint results will be followed ...and if they follow them long enough ( say 2 yrs for event lines to clearly diverge )..hopefully AMRN can use them to increase their Level of Evidence rating .
By the way ..from the Oct CC
Reimbursement decisions due from France , Italy and Spain by end of 2022 or early 2023
Kiwi
Recent AMRN News
- 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
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- 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
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- 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
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- Amarin to Report Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on February 25, 2026 • GlobeNewswire Inc. • 02/11/2026 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:06 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:05 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:04 AM
- Amarin Applauds Breakthroughs In Therapies For Patients With Elevated Triglycerides; Company’s VASCEPA®/VAZKEPA® (Icosapent Ethyl) Franchise Well Positioned To Benefit Globally From Broadened Category Commercialization • GlobeNewswire Inc. • 01/09/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2026 12:05:27 PM
- Amarin Announces Preliminary 2025 Financial Highlights and Operational Accomplishments, Including Achieving Positive Cash Flow; Company Well Positioned to Capture Global Growth Opportunities • GlobeNewswire Inc. • 01/08/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:17 PM
