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DewDiligence

12/29/10 12:20 PM

#111674 RE: dewophile #111658

…the others must have [reverse-engineering Sanofi’s process] down to have achieved sameness

That does not follow, IMO. The five criteria for sameness are the easy part of this narrative; the hard part is understanding the “junk” in the Lovenox mixture and ensuring that it is within the lot-to-lot variation of branded Lovenox.