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Biodel Inc. (BIOD) Message Board

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  • biod_factman biod_factman Jul 14, 2010 12:28 PM Flag

    Any scientist types on the board that can comment on possible approval?


    Understand that the FDA process is an ongoing conversation so to speak between the company and the FDA. Regarding the ph III trial, Biodel has already given them the full data which includes the longer term safety data. By PDUFA date the FDA will either approve or give a CRL. A CRL could just ask simple questions or require a new trial. I think if they get a CRL, no new trial will be needed. If they need that new trial then they have already started the prepartion for insulin pump study comparing Viaject vs. Humalog. Would take about a year to complete and it would start after the follow up FDA meeting. So the trial would start around January 2011.

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