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Gilead’s Robust Expanded Access For Remdesivir Signals Confidence In Study Enrollment

 
• By Sarah Karlin-Smith

US FDA has granted about 250 COVID-19 patients expanded access to Gilead’s investigational antiviral; the adaptive trial now underway in US aims for 400 patients.

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The US Food and Drug Administration has granted about 250 US COVID-19 patients expanded access to Gilead Sciences Inc.’s investigational antiviral remdesivir, the agency said Thursday. That relatively high number suggests the agency and Gilead may not be concerned about compassionate use detracting from patient enrollment in clinical trials needed for regulatory approval.

FDA said the data collected from the expanded access program might contribute to its understanding of the drug, but controlled clinical trials will be needed to make a safety and...

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