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MannKind Corp. Message Board

  • amiretiredyet1 amiretiredyet1 Apr 13, 2013 1:45 PM Flag

    Wilson is not responding to 70 negative comments on SA

    Evidently even he doesn’t believe what he wrote.

    And some wisdom from another board …

    "Brian Wilson - FDA agreed to design changes in new trials!!!!
    Mann is a cool head. He knows what the problems were in the insufficient trial.
    Mann's description of the dynamics of HbAic for the revised trial are scientifically sound.
    His approach to enrollment criteria for this trial were modified in ordered to the expected dynamic by requiring higher doses of the long-acting insulin in the chronic diabetics.
    FDA allowed a special monitor to ensure compliance with the modified protocol.
    Poor Wilson - nothing like making a public #$%$ out of himself by demonstrating he does not know the ABCs of diabetics therapies.
    In the Affinity trial, the FDA has authorized us to engage an independent monitor who will review e-diary records and will contact the clinicians responsible for patients that are not complying with the protocol. This should not only #$%$ure reaching a non-inferiority requirements for approval, but hopefully, it may even enable us to show superiority of AFREZZA in HbA1c."

    … and …

    "because of the fear of hypos is so great — because it’s so great, the basal insulins have not been increased in our earlier studies even for AFREZZA patients. For example, in our earlier MKC-117 trial, fasting glucose was supposed to be adjusted to under 120 milligrams per deciliter. However, even though required in the protocol, average basal insulins in that study were not increased. And as a result, the fasting glucose remained too high, masking the advantages of AFREZZA. The average A1C reduction in the 117 trial for AFREZZA cohort WAS ACTUALLY SLIGHTLY BETTER than for the insulin aspart that is NovoLog."

    Again, the 117 study (unlike the 009) showed BETTER results for Afrezza. But Affinity 1 should be better yet because of the data monitoring described above. And all they have to do is not be significantly inferior.

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