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Genzyme/Isis On Track To Submit Severe High Cholesterol Drug Mipomersen In 1H 2011

This article was originally published in The Pink Sheet Daily

Executive Summary

The second-generation antisense drug is four for four in positive Phase III outcomes, but in addition to lowered cholesterol, patients in those studies had elevated liver enzymes, leaving observers to wonder whether FDA will consider the side effect a manageable trade-off for filling an unmet need.

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