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Re: jbog post# 11432

Thursday, 03/27/2014 9:05:24 AM

Thursday, March 27, 2014 9:05:24 AM

Post# of 20689
I think you missed my point. Not saying they will or won't, just saying I don't think those Synthon trial results mean squat to the FDA regarding an interchangeable AB rated generic Copaxone. Like I said, I bet Natco's copax knock off in India would do a-okay in trials (they're not using the same one for their ANDA), but no way in hell that version would get approved by the FDA.

As a side regarding Amphastar, of course there's that whole thing were Amphastar used MNTA's technology to get approved and all :P