FDA Cites ‘Uncertainties’ in Veru's COVID-19 Antiviral Data Ahead of Adcomm

Despite an FDA review team flagging potential “uncertainty” in data presented by Veru, Inc. for a COVID-19 antiviral drug, the issues may not be enough to derail potential Emergency Use Authorization.

On Monday, the FDA presented briefing documents outlining a number of red flags in the data presented by Veru, including a high placebo mortality rate and uncertainty in the identification of a clinically relevant patient population.