Replies to post #86755 on Biotech Values

[DewDiligence]

MNTA:

[FDA] would trust/distrust both companies equally. So can you see any reason that MNTA would have any advantage over TEVA for approval as fully characterized Lovenox.

As mouton said, trust has nothing to do with this.

Teva’s written response to SNY’s Lovenox Citizen Petition indicates that Teva wants the FDA to define sameness as the same degree of inhibition of Factor Xa and Factor IIa as in branded Lovenox. On the other hand, SNY argues—and MNTA agrees—that the FDA should define sameness as the same degree of all of the constituents in branded Lovenox, not just FXa and FIIa.

I think this answers your question.