Followers | 233 |
Posts | 26887 |
Boards Moderated | 0 |
Alias Born | 01/12/2013 |
![](https://investorshub.advfn.com/uicon/377108.png?cb=1701103334)
Saturday, October 19, 2013 7:30:11 AM
The FDA appears to be moving towards ending surrogate endpoints. We need the help of Big Pharma and we need it NOW!
http://www.bioworld.com/content/emdac-asks-cardiovascular-outcomes-amarin’s-vascepa
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee broke with the recent track record of the agency in recommending against an application for a lipid-lowering agent based on a surrogate endpoint, asking instead for results of an ongoing cardiovascular outcomes trial before recommending approval.
Most drugs on the market today are approved with surrogate markers, including ALL the new diabetes medications. Despite the drop in HgbA1c we are still seeing the same or rising CV deaths in type 2 DM patients. Reducing HgbA1c is a surrogate marker it's not a direct marker for CV disease. Yet we use it to approve drugs to decrease the risk of CV disease.
Amarin is using the wrong placebo! We must find out what's killing these people, Diabetes or inflamational risk factors that Vascepa treats.
First, me must present the idea to all recently approve DM2/1 Big Pharma drug companies. This is the start of the FDA pulling surrogate markers and Voided a successful SPA study. It is the destruction of innovation and venture capital investing in Pharma.
Amarin has to contact their past Big Pharma Executives , we must get a petition signed by Big Pharma leaders requesting the FDA not to end surrogate markers and void SPA agreements.
This is where we start:
The science doesn't prove reducing HbgA1c reduces CV events, we use HbgA1c as a surrogate to measure efficacy. Most CV events occurred in persons with MODERATELY elevated HbA1c.
"The risk for cardiovascular disease and total mortality associated with hemoglobin A1c concentrations increased continuously through the sample distribution. Most of the events in the sample occurred in persons with moderately elevated HbA1c concentrations. These findings support the need for randomized trials of interventions to reduce hemoglobin A1c concentrations in persons without diabetes."
In no way am I suggesting a campaign to bash these drugs, ending surrogate markers in the type 2 DM patients will end innovation to help reduce their 4 fold risk at cardiovascular events.
Next all recently approved DM meds:
Byetta, Symlin, Januvia, Victoza, Bydureon, Tradjenta and Onglyza.
Companies:
AMYLIN. Byetta
BMS and AZN. Symlin
I don't have time to list them all.
Someone who can articulate this message please start on a statement we can get signed by these company CEO's and send to the FDA. Ending surrogate markers in an extremely high risk population is destructed to the innovation we are attempting to save lives.
Please
Thoughts?
Williams
Recent AMRN News
- Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress • GlobeNewswire Inc. • 08/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 09:30:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- 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
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- 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
FEATURED Integrated Ventures Acquires 51% Stake In GetTrim.Com (TM), Telemedicine Platform With Focus On Expansion Into Booming GLP-1 Powered Weight Loss Market • Sep 4, 2024 8:45 AM
Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM
PickleJar Launches National "Get on the Bus" Campaign, Unveils Thompson Square Tour Bus Wrap • PKLE • Sep 4, 2024 7:17 AM
Maybacks Global and Inventel Products To Launch Global 24 Hour Shopping Channel • AHRO • Sep 3, 2024 9:15 AM
UC Asset announces plan of management stock buyback • UCASU • Sep 3, 2024 9:00 AM
Element79 Gold Corp Appoints Warren Levy to Board of Directors • ELMGF • Aug 28, 2024 9:51 AM