Friday, April 03, 2020 12:42:58 AM
Problems w Mori(2000) which negate any value in evaluating AMRN patent
1. Baseline (N=19) TG level FOR EPA GROUP reported as 2.01 ± 0.19 mmol/L [x ± SEM]. Converting SEM to sd --> 0.19 * sqrt 19 = 2.01 ± 0.8282 [x ± sd]. 1.96 sd = 1.623. So 97.5% of group have a baseline TG < 3.633 mmol/L == 321.8 mg/dl.(ie expect >18.5 of 19 patients in the EPA group to have a TG < 322). Aren't the patents in question in patients with TG >500?
2. Post treatment decrease in TG levels 21.6% greater for DHA than EPA - so expect LDL-C to increase more in the DHA group. I don't know if it is proper to refer to the Friedewald equation, but LDL-C est as = TC- HDL-C - (TG/5) suggests that decreasing TG by 21% more could increase LDL-C by 4.2% more.
3. Post treatment LDL-C INCREASED in the EPA Group from 4.28 ± 0.19 [x ± SEM] to 4.46 ± 0.10 [x ± SEM] (+ 4.0%) while in the DHA Group from 4.27 ± 0.17 to 4.64 ± 0.10 (+ 8.7%). How do we know a 21% greater reduction in TG levels (by DHA cf EPA) shouldn't be expected to increase LDL-C by this amount over EPA? It seems to concur with the 4.2% expected above.
4. The paper compared the EPA group to the control and the DHA group to the contol - but not to each other. Converting to std dev gives a post treatment LDL-C range [x-sd to x+sd] of 4.024 - 4.896 for the EPA group and 4.248 - 5.052 in the DHA group. I think we would need to know the TG and LDL-C levels for each individual patient to know for sure, but I'd bet there would be enormous overlap between these 2 groups and some stats guru could prove.
Recent AMRN News
- 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
- 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
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/26/2024 12:00:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/24/2024 09:31:21 PM
- Amarin Chairman & CEO Issue Letter to Shareholders • GlobeNewswire Inc. • 01/22/2024 12:30:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM