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DewDiligence

07/29/20 4:57 PM

#233943 RE: DewDiligence #232306

BMY/BLUE resubmit bb2121 BLA following May 2020 RTF:

https://www.businesswire.com/news/home/20200729005776/en

This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.