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MannKind Corp. Message Board

  • kevinmik kevinmik Jul 21, 2014 9:22 PM Flag

    Mannkind Did Not Get Everything They Wanted On The Label - That's Why No Conference Call

     

    The FDA did not screw Mannkind with the clean label it approved, but they also did not do them any favors by approving a label that does not clearly identify Afrezza as being a superior first in class ultra-rapid acting insulin. This may be a sticking point with potential partners, but I hope not.

    1) Did Not Get Classified As "Ultra-Rapid Acting Insulin"
    2) Did Not Get Classified As 1st In Class
    3) Did Not Get Recognized As Causing Less Hypoglycemia
    4) FDA Label Looks To Position Afrezza As An Alternative Rapid-Acting Insulin Choice Offering Greater Convenience.
    Overall the label is very good, but I expect it wasn't the final label they were hoping for. Big Pharma could be playing hardball saying the label only allows they to position Afrezza as another rapid acting insulin with convenience

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