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DewDiligence

01/26/11 5:55 PM

#113376 RE: orangeone #113372

I'm not sure to understand where the assertion comes from that CMC requires characterizing the product in these ways…

CMC comes into play insofar as reverse-engineering SNY’s manufacturing process for branded Lovenox is an obligate step for FDA approval of a generic Lovenox from any company. There may be ways to do this without MNTA’s IP, but that’s unclear.