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Re: acgood post# 116007

Monday, 03/07/2011 3:01:14 PM

Monday, March 07, 2011 3:01:14 PM

Post# of 257251
Wheeler Re Copaxone trial 33:30 mark.

"well i'm not going to confirm or deny what we are doing. i did hear the same thing though that people are hearing that [couldn't hear the question though all that well...something about MNTA or Mylan initiating a copaxone clinical trial]. Our position continues to be on this that we're and injectable generic that should be eligible for the waiver. Any clinical work that's done here really is supportive of identity, which is what we do. So it is possible that the FDA could ask for some clinical work, we believe that would only be supportive of full identity rather than kind of a biosimilar track where you are doing efficacy trials to try to get approval."

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