Only the FDA knows for sure, but what would be the FDA’s impetus for lowering the standard?
I cannot think of any reason why they would lower the bar. I was just thinking out loud whether the FDA's bar might be lower than MNTA's technical abilities. Assuming mL is the standard, then the debate isn't whether tL meets so called chemical sameness, immunogenicity requirements, etc., but whether tL meets mL standards. If mL is the standard there will be no tL approval, IMHO.
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