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MannKind Corp. Message Board

  • kevinmik kevinmik Aug 15, 2013 7:04 PM Flag

    Study Results Completely Satisfies The FDA's CRL Concerns....Drug Will Be Approved For Type I & Type II...

    These are the primary concerns the FDA wanted Mannkind to satisfy before they would issue an approval and Study 171 & 175 achieved them.

    Study 171:
    Primary Efficacy Goal Was HbA1c Non-Inferiority Between Dreamboat and Aspart And It Was Achieved
    Prmary Safety Goal Was Comparative Pulmonary Change In Lung Function Between Dreamboat And Medtone And There Was No Statistical Difference Between The Two Device Which Will Allow Mannkind To Bridge All Prior Pulmonary Data From Previous Trials Over To Dreamboat. The Safey Goal Was Achieved

    Study 175:
    This Study Had Only One Primary Goal And That Was Efficacy To Demonstrate HbA1c Superiority Between Technosphere Insulin and Technosphere Placebo And It Was Achieved.

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