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.
Gilead’s Robust Expanded Access For Remdesivir Signals Confidence In Study Enrollment
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.