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Re: DewDiligence post# 110628

Friday, 12/10/2010 6:59:05 PM

Friday, December 10, 2010 6:59:05 PM

Post# of 257251
MNTA: Dr. Roach: ...So that, by the time you get to drug product through these learnings, you may, in fact, have a drug product that may be more similar to the reference product that the differences you observed between lot-to-lot in the reference product.

I think this says it all irt MNTA's Copaxone aNDA confidence level, IMO.
It's no wonder Teva is on CP #3, due to worry.

"If we don't succeed, we run the risk of failure."
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