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MAP Pharmaceuticals, Inc. (MAPP) Message Board

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  • fastmoneypete fastmoneypete Mar 25, 2012 3:36 PM Flag

    Stop The Insanity- Think Logically

    If I may add, the two noteworthy inhalable drug therapies (Pfizer's Exubera and Mannkind's Afrezza) mentioned here ad-nauseam were failures for a number of reasons.
    Briefly,
    Exubera - While approved by the FDA, Pfizer withdrew the product from the market. Problems with a) difficulty in the delivery and the conversion of accurately measured doses b) possible lung function degradation, while temporary, due to the complex large protein of insulin, c) bong-size pipe (IE embarrassingly cumbersome delivery method), and d) 2x cost of injectable therapy.
    Afrezza - The first CRL issued requested additional data on the clinical utility of Afrezza and more specifically the comparison between MNKD's Medtone safety and efficacy vs. the Afrezza's redesigned second-generation Dreamboat being submitted in the NDA. So MNKD attempted to simply take in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to late-stage trials conducted using its current-generation MedTone inhaler, and subsequently the FDA said no in it's second CRL issued - where it asks the company to conduct two clinical trials to run a head-to-head comparison of the Medtone inhaler and the next-generation Dreamboat inhaler that will be marketed with Afrezza.

    So while the Exubera and Afrezza had some serious issues, they are all NON-ISSUES with Levadex. In addition, while I will concede that the FDA has been spotty with RDD approvals, Levadex has shown a) undeniably superior efficacy vs. injectable DHE and b) safety concerns (both in the NDA submitted drug formulation and delivery device) that are statistically nil.

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    • I could have a serious argument with you about Afrezza having "serious issues". In fact, Afrezza is a solution for them. Know the facts..somewhere along the way the FDA changed it's mind about allowing the bench data from the new inhaler as a substitute for the original Medtone inhaler where the trials were done on. They now want comparative between old and new inhalers...it is BS. The new inhaler is far superior using less drug to achieve the same result. There were no issues with the drug itself. Once the testing is complete on the new inhaler it will be approved. Afrezza will eventually be one of the biggest drugs of all time. Long VVUS, MAP, MAKO as well as very long MNKD.

 

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