BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push

 
• By Sarah Karlin-Smith

AstraZeneca’s Imfinzi lung cancer advisory panel, which offered insight into why sponsors do not always follow agency advice, likely is a preview of the hurdle facing Bristol Myers Squibb’s Opdivo application for the same indication. 

two sets of business people with giant speaking bubbles that are disconnected and broken showing visual of communication breakdown
The Imfinzi ODAC meeting revealed potentially broader communication problems between the FDA and industry. • Source: Shutterstock

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