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Re: HDGabor post# 28692

Wednesday, 06/04/2014 5:54:25 AM

Wednesday, June 04, 2014 5:54:25 AM

Post# of 427543
con’t:

Based on FDA' logic I changed my mind and I think we have to stop Reduce-IT (however it will be successful), since it will not provide enough evidence relevant to the specific Vascepa coadministration indication to warrant grant of the indication, however R-IT demonstrated unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs, so FDA will allow the indication for other non-statin lipid-modulating drugs (ie.: Lovaza and Epanova), but not for Vascepa ……
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