Replies to post #119193 on Biotech Values

[DewDiligence]

There is a difference between PK/PD, especially aggregate PK/PD, and measuring a biomarker of activity (which was what investorsgold asked about when he compared to anti-IIA activity for Lovenox).

I assumed that investorgold was asking about PK/PD (even though he didn’t phrase it that way) because PK/PD rather than elucidation of the MoA is the issue of consequence for approvability of the Copaxone ANDA.

Obviously this might be excusable since plenty of aspects of Lovenox are not fully understood/characterized and yet m-enox was approved.

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.