In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.

Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.

The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.

President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.