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Re: DewDiligence post# 943

Wednesday, 01/20/2021 9:51:49 AM

Wednesday, January 20, 2021 9:51:49 AM

Post# of 1162
Two new PDUFA dates for Opdivo…

5/25/21 for Opdivo/chemo in first-line gastric cancer, based on CHECKMATE-649 study:
https://www.businesswire.com/news/home/20210120005166/en

5/20/21 for Opdivo monotherapy in adjuvant esophageal or gastroesophageal junction cancer (following chemo/radiation in the neoadjuvant setting), based on CHECKMATE-577 study:
https://www.businesswire.com/news/home/20210120005097/en

Both sBLAs received an FDA priority review.

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