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DewDiligence

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DewDiligence

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Re: gfp927z post# 54626

Saturday, 11/10/2007 9:58:02 AM

Saturday, November 10, 2007 9:58:02 AM

Post# of 257265
>MNTA – Were efficacy and safety trials done on the Momenta drug beyond what is normally required for regular generics?<

ANDA’s do not require de novo clinical trials. If this ANDA ends up requiring them, it will be the first.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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