Biotech Values

[ThomasS]

MNTA: Irt generic enoxaparin, I keep coming back to the same statement from TEVA for insight on suitability, unless and until they have refined their capabilities and resubmitted to the FDA's satisfaction:


C. The Lack Of “Full Characterization” Of Enoxaparin Does Not Bar Generic Approvals


{It may bar Teva if MNTA fully characterized. We don't really know if MNTA was able to, however. On the other hand, it may only be necessary for MNTA to have more fully characterized than Teva, even if not completely.}

{I also found Teva's statement amusing as they seem to be dictating policy to the FDA.}