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GSK Approval Plan For COX-2 Inhibitor Includes Lower Doses In Phase III

This article was originally published in The Pink Sheet Daily

Executive Summary

The company will experiment with lower doses of its COX-2 inhibitor, 406381, to mitigate the cardiovascular risk seen with the class, CEO Garnier says. While FDA has “blessed” GSK’s Phase III program, testing multiple doses will give GSK “more chances to win.” The agency is also asking for a cardiovascular safety study.

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