Weaknesses In Gilead's Remdesivir Trial Designs Unlikely to Impact Approval Prospects In US

Urgency of the COVID-19 crisis, political pressure, and trends in FDA reviews all point in favor of Gilead, despite the company's decision to conduct open-label Phase III trials for remdesivir and only one study with a control arm.

Gilead sign at headquarters in Silicon Valley. Gilead Sciences, Inc. is an American biotechnology company that researches, develops and commercializes drugs - Foster City, California, USA - 2020
Gilead said speed and a desire to test varying dosing regimens influenced their trial design decisions. • Source: Shutterstock

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