Replies to post #66672 on Amarin Corp Plc (AMRN)

[Sam81]

Could this be a new lawsuit by Merck, 1A right, truthful and non misleading since Improve-It results showed that a combination treatment known as Vytorin, comprising Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death compared with simvastatin alone by 6.4% but the panelists voted 10-5 against allowing Merck to make the claim, saying they were not convinced the benefit was clinically meaningful, especially since some patient data was missing.

"The benefit here is small," said Dr. Milton Packer, distinguished scholar in cardiovascular science at Baylor University Medical Center. "It is not robust. You blink and you miss it, and you wonder if you care or don’t care."

The FDA is not obliged to follow the advice of its advisory panels but typically does so.

[Biobillionair]

Raf--

"We believe Improve-It showed that ezetimibe in combination with a statin offers a significant benefit to high-risk patients with coronary heart disease," he said."

I think Merck will get a reduction of CVE in diabetics label. Study also heightened doubts about LDL being an approval biomarker...

The FDA approved injectables solely based on lower is better theory...this may in fact double the hemorrhagic stroke risk. Vessel rupture instead of blockage.

Thanks for posting.

BB

[sts66]

Hmmm....that article made me think of something.....since Merck has the trial data that *did* show efficacy in 75+ yr old diabetics, perhaps they will seek a 1st A right to talk to docs about it? May not be worth the trouble though, as Vytorin patent expires in April 2017.