Amarin Corp Plc (AMRN)

[Biobillionair]

Amarin longs please read:

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