CJ... Great Post! Whats interesting.... is the very bottom "you are not required to send samples of future lots..."
so at one point.... in the beginning phases of manufacturing: Genentech must have had to send batches to CDER (Center for Drug Evaluation and Research) for testing... review...etc
I just wonder how many lots of Bavi that have been sent out for review ... : )
GLTA!
"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!