Biotech Values

[DewDiligence]

…but how does MNTA/TEVA prove [sameness] in a manner that the FDA will accept?

Randy, it sounds as though you have not read the MNTA ReadMeFirst—at least not thoroughly.

I think the answers to your questions can be found in such RMF entries as #msg-25473104, #msg-28865474, and #msg-30647865. If you find these discussions unsatisfactory, there are publications in peer-reviewed journals that provide considerably more detail. Regards, Dew