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DewDiligence

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DewDiligence

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Re: 10bags post# 235996

Friday, 08/13/2021 2:45:05 PM

Friday, August 13, 2021 2:45:05 PM

Post# of 252412
SESN receives CRL for Vicineum in NMIBC:

https://finance.yahoo.com/news/sesen-bio-receives-complete-response-184000117.html

The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.

Other than those things, the BLA is in pretty good shape, LOL.

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

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