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Biodel Inc. (BIOD) Message Board

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  • biod_factman biod_factman Sep 29, 2011 3:26 PM Flag

    File the glucagon NDA

    all I can say is good luck filing without any real trials. technically you don't need a ph III in 505b2, but what evidence are you going to use to show non inferiority? they don't even have a ph I for glucagon. you won't find one 505b2 that hasn't done a ph III in their submission. let alone a ph I or II.

 
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