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Re: ggwpq post# 25190

Sunday, 02/09/2014 12:59:35 AM

Sunday, February 09, 2014 12:59:35 AM

Post# of 425804
ggwpq - No proven benefit in the eye's of the FDA (I could have added that yet thought it was obvious...) If the FDA thought or thinks there is a Proven Benefit or reducing Trigs below 500, they would or should or still can approve Vascepa with a modified label...

As of now they have NO PROOF of a Health Benefit of reducing Trigs below 500.

I like you completely disagree with that position YET the FDA is fact driven so once Amarin can produce something that shows a benefit of reducing Trigs below 500, we can apply for that benefit and sell the drug for that reason (with the FDA's backing)...

The key is to get their backing. They are basically the Gate Keeper to Doctors...



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