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DewDiligence

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DewDiligence

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Re: Bio_pete post# 111410

Thursday, 12/23/2010 5:26:27 PM

Thursday, December 23, 2010 5:26:27 PM

Post# of 257262
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.

Regards, Dew

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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