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Posted On: 01/16/2021 8:36:01 AM
Post# of 148903
Can a trial doctor please speak to this new guidance from the FDA regarding MABS for EUA and BLA approvals. I have read through it twice and do not understand what data for “potency assay” is. Does CytoDyn already have this data?
file:///var/mobile/Library/SMS/Attachments/3e/14/8CE115AB-22FE-4F9F-BBE0-F3775BEF76B3/COVID%2019-Potency-Assay-Considerations-for-Monoclonal-Antibodies%20.pdf
file:///var/mobile/Library/SMS/Attachments/3e/14/8CE115AB-22FE-4F9F-BBE0-F3775BEF76B3/COVID%2019-Potency-Assay-Considerations-for-Monoclonal-Antibodies%20.pdf
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