• 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.