Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

your point 2) is taken

However on point 1) I still FDA is not anywhere close to determining what constitutes sameness in the case of copaxone. Otherwise they would have said " if X, Y and Z are shown to be the same, the ANDA would be approved " or would have replied positively or negatively to Peptimmune's CP.

The fact that it said it is too premature to talk about how to determine sameness , implies to me , FDA is nowhere near reviewing MNTA's ANDA or in consensus with MNTA's ANDA..