Global Blood Therapeutics (NASDAQ:GBT) slips 5% premarket on light volume on the heels of a bearish report by STAT News’ Adam Feuerstein who cites the risk in securing accelerated FDA approval for sickle cell med voxelotor.
In June, the company reported positive data from a Phase 3 study, the only one it plans to conduct to support its marketing application that will rely on a surrogate endpoint (corporate presentation, slide #24) to demonstrate efficacy, a criterion that the FDA has never approved for sickle cell disease.
Previously: Global Blood -7% despite positive data from sickle cell drug trial(June 27)
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