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Re: genisi post# 92823

Sunday, 03/21/2010 10:13:31 PM

Sunday, March 21, 2010 10:13:31 PM

Post# of 257648

...odds for generic Copaxone to be approved without clinical trials are close to zero…

You’ve said this multiple times on this board, but you’ve never backed it up with a credible argument, IMO.

If the FDA wanted clinical trials to underpin its review of generic Copaxone, the FDA would presumably not have accepted NVS/MNTA’s application for review under the 505j (ANDA) pathway.


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