I was looking at this, looks like they lots of iss
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Posted On: 12/13/2019 5:17:30 AM
Re: BlackDoggie #12583
I was looking at this, looks like they lots of issues with their inspection, including manipulating data. Looks like the just resubmitted the BLA, after a year delay fixing that.
https://www.fda.gov/media/120248/download
From the latest slides, it looks like AGC Bio is the other manufacturer for Cydy.
From the fact sheet link below.
AGC Biologics has successfully manufactured more than 200 biologics, both mammalian and microbial, for pre-clinical studies through commercial supply.
https://cdn2.hubspot.net/hubfs/1924513/Fact%2...87_web.pdf
http://www.agcbio.com/about_us
https://www.fda.gov/media/120248/download
From the latest slides, it looks like AGC Bio is the other manufacturer for Cydy.
From the fact sheet link below.
AGC Biologics has successfully manufactured more than 200 biologics, both mammalian and microbial, for pre-clinical studies through commercial supply.
https://cdn2.hubspot.net/hubfs/1924513/Fact%2...87_web.pdf
http://www.agcbio.com/about_us
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