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Re: jbog post# 11427

Thursday, 03/27/2014 7:33:40 AM

Thursday, March 27, 2014 7:33:40 AM

Post# of 20689
thanks, jbog.
I think it is more positive than if it fails. This result at least proves TEVA's claims were wrong. Copaxone is not hard to copy. At least 3 companies have done that. FDA will approve all of them before the end of 2015.
From last cc, CW commented that Synthon followed EMA rule to do p3, it may not be accepted by FDA.
Another thing is that, MNTA ANDA is different pathway from Synthon ANDA. Synthon was late to the party in 2011, in order to get a piece of pie, it tried to short-cut by clinical trials which FDA does not require.
MNTA may slide further until TEVA's appeal result.