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dewophile

12/29/10 9:09 AM

#111658 RE: DewDiligence #111656

No, it also leaves reverse engineering of the Lovenox manufacturing process



huh? the others must have this down to have achieved sameness

i think we're hanging our hat on immunogenicity hurdle here for mnta exclusivity (and perhaps supply chain as zip pointed out since biologic starting material varies batch to batch adn requires analytics prior to processing - something mnta stated in their approval cc)