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Re: The Dark KnaDDir post# 196520

Sunday, 12/12/2021 1:23:33 PM

Sunday, December 12, 2021 1:23:33 PM

Post# of 236694
In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA filing requesting additional information.
https://www.sec.gov/Archives/edgar/data/0001175680/000155837021004250/tmb-20210228x10q.htm

I would like to know the specific date for BLA 761144 too.


One thing is certain tho, BLA 761145 is signed NICOLE J GORMLEY
05/01/2020 12:55:59 PM

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761145Orig1s000ltr.pdf

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