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Posted On: 11/11/2020 9:11:15 AM
Post# of 148899
Re: onestepahead #65013
They will apply for EUA, if CD-12 is halted for efficacy at 75% or, if not, when it is completed. - Didn't seem to me they will unblind interim results and apply based on this, but perhaps after Lilly's approval that has again lowered the bar they might change their strategy...
EUA is less bureaucratic and complex, and a full BLA for full approval will take a couple of months longer to complete and approve (see GILD).
EUA is less bureaucratic and complex, and a full BLA for full approval will take a couple of months longer to complete and approve (see GILD).
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