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Posted On: 05/07/2019 12:13:44 PM
Post# of 149546
Thank you misiu! That is what I thought, but wasn’t 100% sure. I would think it is unlikely that mono gets early approval (before completion of pivotal trial), but I would think that all sBLAs will be quicker as the primary changes will only be in the clinical results portion of the BLA (CMO and non-clinical should be well resolved in the combo BLA).
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