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MannKind Corp. Message Board

  • purge_dc purge_dc Apr 12, 2011 5:35 PM Flag

    Day Two No FDA Update

    Day two no new news about the FDA meeting!

    First we were canceled over potential of a government shutdown, the shutdown was avoided, and now we have no idea what is going on!

    Is MNKD Bushleague?

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    • Of course it could be about finacial corruption as you suggested. I just hope that it is not the reason as I would like to believe that our government and way of life have standards that make me believe in it still.

      Dr. Hamburg was appointed to the head position of the FDA by President Obama and as such, I still believe that she is an honest person. I also believe, but have no knowledge of, that she is well aware of the MannKind saga, including this last fiasco on the meeting cancellation.

      I really hope that the FDA jerking MannKind around is not based upon corruption.

    • Purge,

      There was a video I believe from December 2010 where Al Mann was sitting in the audience and Dr. Margaret Hamburg was on the stage accepting comments/questions from the audience. I cannot find the video but I do recall Al ripping into the FDA and mentioning several of its shortcomings and just plain venting his frustrations with the entire process of filing an NDA.

      Al was also a guest on another video seen on this MB hosted by Michael Milken, who was convicted of securities and reporting violations but was never convicted of racketeering or insider trading, despite great evidence to the contrary. He escaped those charges on plea bargaining.

      During the Milken show, Al took another hefty slug at the FDA and has found every opportunity to mention the FDA in his most recent remarks.

      Some of Al's remarks tried to show understanding with the FDA but he always portrays himself as the FDA spokesperson, which he is not.

      I really think with the 2 FDA delays, then 2 unusual CRL's and now this meeting cancellation that seems quite peculiar, that the FDA just does not like Al Mann.

      I wish it were not so but I have never seen a biotech CEO speak out and sometimes almost on behalf of the FDA.

    • How is this a reflection on MNKD?

 
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