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  4. CytoDyn Inc (CYDY) Message Board

chazzle and My69z, I had totally forgotten abou

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Post# of 155613
(Total Views: 682)
Posted On: 05/21/2024 11:39:56 PM
Posted By: Enjay
Re: My69z #143516
chazzle and My69z,

I had totally forgotten about AGC - interesting topic. For those not familiar with AGC, this is from a 2-22-24 S-1 (I looked for the most recent document to insure there had not been any changes):

Quote:
We previously engaged Samsung and AGC Biologics, two global contract manufacturing organizations (“CMOs”), to initiate the scale-up to commercial batch quantities of product and develop the necessary controls and specifications to manufacture product on a consistent and reproducible manner. We also contracted with suitable CMOs to fill, finish, label, and package product into the final commercial package for commercial use. In order to commercialize product, this scaled-up material will need to be validated under best practices and demonstrated to meet approved specifications on an ongoing basis. GMP material will be produced as needed to support clinical trials for all therapeutic indications and until commercial product is approved by the FDA. We will rely on CMOs for all of our developmental and commercial needs.



https://www.sec.gov/Archives/edgar/data/11756...x424b3.htm

One of the two AGC links has this statement below the video:

Quote:
AGC Biologics is producing a key molecule in this drug.



The reporter in the video said AGC makes a key ingredient in this drug. Can someone please explain this. Do they actually make the finished product?

Thanks


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