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Biodel Inc. (BIOD) Message Board

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  • biod_factman biod_factman Sep 1, 2010 10:34 AM Flag

    FDA Approves name

    Actually it does mean a lot. The trade name is something that is later in the FDA NDA process. A lot of applications never get that far b/c the FDA gets held up on an earlier part of the application. They just don't bother with this part if they think they are far away from approval (like making them do another trial). So I think this news is more positive then most people realize. I think this improves the chances of first pass approval.

 
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