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Re: DragonBits post# 99817

Tuesday, 07/27/2010 9:58:04 AM

Tuesday, July 27, 2010 9:58:04 AM

Post# of 257253

It seems to me that by selling Lovenox, MNTA can prove safety by examining actual outcomes of patients.

Apart from the possibility of a newly introduced manufacturing impurity—a risk that applies to branded Lovenox as much as the generic—nothing in NVS/MNTA’s generic could cause a safety problem. The reason is that the variation between an arbitrary lot of NVS/MNTA’s generic and an arbitrary lot of SNY’s branded Lovenox is as small as the variation between two arbitrary lots of branded Lovenox.

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