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DewDiligence

11/13/10 7:36 PM

#108887 RE: flatlander_60048 #108878

I think the Omnitrope case was not a criticism of FDA. Perhaps FDA was pleased to have the Court provide the interpretation of their review authority since it helped clear up the gray areas. I don't think the Omnitrope matter hurt NVS' standing with FDA.

I agree with your analysis. The only reason Omnitrope deserves to be considered in this discussion is that NVS executives had been publicly critical of the FDA for its failure to act before finally deciding to go to court.