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DewDiligence

03/07/11 5:56 PM

#116049 RE: pollyvonwog #116045

..if indeed it turns out to be preemptive, why wouldn't Sandoz/MNTA have done it earlier?

As noted in #msg-60686112, injected drugs typically don’t need bioequivalence studies; hence, NVS/MNTA may have deferred running such a study until they could ascertain that this matter is on the critical path.

It's also my understanding that these studies are pretty small…

Yes—small and quick.