Biotech Values

[pollyvonwog]

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

It's also my understanding that these studies are pretty small (24-36 people) yes?

ANDAs for injected drugs ordinarily don’t need bioequivalence studies because such drugs, by definition, don’t have the variability in bioavailability that comes from variability of dissolution in the GI tract. However, it’s conceivable that the FDA may nevertheless want a bioequivalence study for NVS/MNTA’s generic Copaxone. If there is any chance of this, it would make sense for NVS/MNTA to conduct such a study prophylactically rather than getting hit with a deficiency letter later.