My take is the new FDA potency guidelines are not
Post# of 151690
(Total Views: 641)
Posted On: 01/16/2021 3:55:32 PM
My take is the new FDA potency guidelines are not applicable to leronlimab, which I believe is classified as a hyperimmune globulin. However, I'm sure if assay results were presented to reinforce the MOA, it would make approval even stronger.
"Vaccines, hyperimmune globulins, gene therapies, cell therapies, and convalescent plasma are not within the scope of this guidance."
"Vaccines, hyperimmune globulins, gene therapies, cell therapies, and convalescent plasma are not within the scope of this guidance."
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