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."
-Dan Quayle