U.S. Food and Drug Administration staff cited concerns on Tuesday with the design and analysis of clinical studies intended to support the effectiveness of Gilead Sciences's experimental cystic fibrosis drug.
"There are concerns that assumptions used in the analysis could have been determined retrospectively," the staff said in their 48-page briefing document.
Dec 8 · 3:17:00 PM · Source: Reuters
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by Michael Oliveto
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