Replies to post #119204 on Biotech Values

[iwfal]

because PK/PD rather than elucidation of the MoA is the issue of consequence for approvability of the Copaxone ANDA.

Well, that isn't what the FDA said in their five criteria for enox. (I understand the contention that that criteria will be different for Copaxone, but until the FDA releases a new list for Copax it is a risk which we will all judge differently.)

You’re half right and half wrong. MNTA almost completely characterized Lovenox, but this does not mean that the MoA of Lovenox is fully (or almost fully) understood

My bad - I should have said

plenty of MOA aspects of Lovenox are not fully understood/characterized

[investorgold2002]

I wasn;t asking PK/PD ..Actually i was asking markers for activity...
because that is the 4th criteria for "sameness":
Equivalence in Biological and Biochemical Assays