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DewDiligence

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DewDiligence

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Monday, 05/02/2022 9:28:05 AM

Monday, May 02, 2022 9:28:05 AM

Post# of 251939
CHRS receives FDA CRL re CMC issues:

https://finance.yahoo.com/news/coherus-junshi-biosciences-receive-complete-110000485.html

The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable. Coherus and Junshi Biosciences plan to meet with the FDA directly and expect to resubmit the BLA by mid-summer 2022. The Agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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