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Re: None

Tuesday, 06/25/2013 10:02:40 AM

Tuesday, June 25, 2013 10:02:40 AM

Post# of 426332
Somebody posted this MSG on SA. Care to comment?

"I can see it now....
Final Question: "Do the benefits of approving Vascepa, prior to having any CV outcomes data, outweigh the risks?"

When answering that, keep in mind that in the Anchor Trial, HDL Cholesterol DECREASED

I'm sure the standard rebuttal from the peanut gallery will be the decrease in LDL.

But keep in mind that patients in this population already have LDL levels below 100 mg/dL, which is classified as "ideal".

However, average HDL levels are below 40 mg/dL, which is classified as "poor."

Since Vascepa DECREASES HDL, it is just making a bad thing worse.

Also, a common theme that is brought up at Advisory Committees is the quality of data/trial design. There is no doubt that the abnormal % end point increases in the placebo arm will be scrutinized and called into question. Once the ridiculous placebo effect is removed and one looked solely at % change from baseline, the benefits are quite underwhelming"
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