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DewDiligence

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DewDiligence

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Re: orangeone post# 113372

Wednesday, 01/26/2011 5:55:31 PM

Wednesday, January 26, 2011 5:55:31 PM

Post# of 257273

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.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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