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DewDiligence

02/28/23 11:15 AM

#245689 RE: DewDiligence #244205

Opdivo PDUFA date for adjuvant melanoma—>10/13/23:

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900042.html

The corresponding MAA has been validated by the EMA, starting the review clock.

The sBLA and MAA are based on the CHECKMATE-076 study, which showed HR=0.42 for the primary RFS endpoint (#msg-170239823).