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Re: bidmark post# 43017

Saturday, 02/28/2015 9:03:50 AM

Saturday, February 28, 2015 9:03:50 AM

Post# of 423526
HD, the following is what FDA used as an argument against Vascepa being granted NCE

"a drug product with a single active ingredient may contain multiple active moieties. The identification of the active moieties of a naturally derived mixture depends on how well the mixture can be characterized, whether the component in question is consistently present in the mixture, and whether there is evidence that the component is clinically active."

Do you think this argument is a strong one? TIA.
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