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DewDiligence

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DewDiligence

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Re: dewophile post# 54404

Tuesday, 11/06/2007 1:50:59 PM

Tuesday, November 06, 2007 1:50:59 PM

Post# of 257580
>MNTA …the FDA contends that it may not be, or else why require immunogenicity studies.<

The FDA has not yet said they will require immunogenicity studies, although they may do that. All they’ve said so far is that they want more information vis-à-vis immunogenicity from all of the generic-Lovenox applicants (Teva, WPI/Amphastar, and Sandoz/MNTA).

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

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