Wednesday, October 21, 2020 11:08:05 AM
My take is the 700mg dosage was showing increased efficacy over 350mg. This brought Mono play into the picture. If Nader would have known the monkey wrench that was being thrown into the BLA process w the 700mg dosage he would have never adhered and taken the FDA’s advisement. Now here we are w the BLA floating while trying to complete the 700mg data and address a syringe technicality.
This is not my area of knowledge and obviously hiring people that do get it should have been brought on board during the submission process. Better late than never - fingers crossed they get it right this time.
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