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investorgold2002

04/03/11 10:21 PM

#2318 RE: DewDiligence #2317

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..