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  • curiouscustomer curiouscustomer Oct 10, 2009 3:42 PM Flag


    Will NOT LAUNCH with medtone inhaler. Mr. Mann stated during the Morgan Preso that MNKD will only launch with Dreamboat - and that FDA approval of the Dreamboat could be a major hurdle to overcome for a January launch date (2010) - IF THE FDA doesn't approve Dreamboat by the PDUFA date.

    As of the Morgan Preso, MNKD had submitted additional information to the FDA regarding the Dreamboat, but had not been given an indication as to whether or not the Dreamboat was going to be approved by the FDA nor was MNKD made aware as to the manner in which the approval would be granted.

    MNKD shareholders (and shorts alike) have two distinct issues to stay on top of:

    1. the FDA approval of Afresa and the technosphere delivery of the insulin. (1/16/2010 - PDUFA date)

    2. the FDA approval of the dreamboat inhaler - delivery method. (No approval date or approval track has been reported by the MNKD or the FDA)

    All, just my humble opinion.

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