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genisi

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genisi

Re: DewDiligence post# 2150

Friday, 03/27/2009 2:47:54 AM

Friday, March 27, 2009 2:47:54 AM

Post# of 3595
I don't think the FDA knows at this point what it wants and therefore, I don't think that the fact that they have accepted the Copaxone ANDA for review reflects anything about the approvability of any ANDA or NDA. If you agree that some form of clinical trials to show safety and efficacy will be necessary, then we do not differ that much.
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