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mcbio

12/23/10 6:57 PM

#111420 RE: DewDiligence #111412

Two points:

• NVS/MNTA’s ANDA is not seeking approval for a formulation change to Copaxone; to the contrary, NVS/MNTA’s version of Copaxone is a reverse-engineered replica of Teva’s branded Copaxone that will likely have less variation from a given lot of Teva’s Copaxone than two lots of Teva’s Copaxone will have from each other.

• The language in today’s Teva PR about Copaxone’s MoA emanated from Teva, not the FDA
.

Great post DD, as usual.

Not hoodwinked,

mcbio