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MannKind Corp. Message Board

  • twobit_dotconnector twobit_dotconnector Feb 13, 2012 7:35 PM Flag

    FDA Decision Date

    From all available information, especially the information posted on this board that shows "almost" all sites actively recruiting, and a 6 month trial period for patients.

    Optimistically, lets say trials begin May 1st. That means trial completion by November 1. Six weeks to get data to MNKD. 2 1/2 months for MNKD to submit. We are now at March 1, 2013. Note - these are optimistic assumptions. I cannot see anyway MNKD has an FDA decision in 2013.

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    • Aren't the traisl 12 weeks and not 6 months?

    • I just drove by two houses (or, more accurately, two domestic compounds)
      One is on Nebreska Ave NW, the other 36th St NW here in DC.

      One is owned by a US Senator whose husband is filthy rich from defense contracts oiled to him by his wife's cohorts; her name is Diane Feinstein D. Ca. US Senator.

      The other "compound" (both take up a full city block) belongs to a woman whose husband is a honcho at Renaissance Hedge Fund, investor in Biotech and Big Pharma. Her name is Margaret Hamburg MD, Commiss of FDA.....her compound is a city block long as well.
      Both places dwarf , completely dwarf, any five houses put together,,,,,

      Need there be any better explanation of what DC is here in 2012?

      Disgusting is an apt word in my opinion

    • not sure the disconnect here. I am not hearing a 2014 date, rather and easy '13. Seems the shorts and late comers want your shares?

      From the Q3 2011 Earnings Call Transcript Nov 3 2011 indicates Ti trials underway to some degree long ago. Dont neglect to read the the Q&A. (see http://seekingalpha.com/article/305499-mannkind-s-ceo-discusses-q3-2011-results-earnings-call-transcript)


      Richardson/ Edstrom; "Study 171 is an open label study in patients with Type 1 diabetes."...
      " screened our first patients in the Type 1 study on September 19, and we are well underway with recruitment and enrollment in that study. The first patient's first visit in the Type 2 study is expected to take place a little bit later this month and we remain on schedule to hit that target." ... "we need only do simple spirometry rather than the extensive measures of pulmonary function" ... "12-week titration period, followed by a 12-week observation" ...


      Alfred E. Mann: " a key message in this CRL was that the fairly short clinical trials in both Type 1 and Type 2 patients would be needed to compare the new device to that used in our previous clinical studies of AFREZZA, including the 2-year MKC-030 trial. " ... "we expect to complete both of these studies by the end of 2012 and to submit the results to the FDA a few months later. That should lead to a PDUFA date 6 months after filing in 2013. " ... "During our next quarterly call in February, we should be in a better position to more accurately estimate the completion dates for the 2 ongoing clinical studies."


      LONG (as it takes) MNKD

    • full enrollment expected by April 15 + 24 weeks trial + 60 days to submit.

      PDUFA date late August to no later than SEPT. 2013. I'm currently enrolling and it appears to be going smoothly.

      YOUR SHORT BIAS IS SHOWING !!!

    • AL stated that the trial data would be ready to submit to the FDA by Feb. 2013. The FDA will probably take their full allotment of time = six months for review which means Aug/Sept timeframe next year. Given the logic for these trials it would be so simple to give MNKD a conditional approval (for at least type II diabetes) with final approval granted with a successful trial(s) review. However,the FDA finds it best let the diabetics wait and push MNKD to drain finances to prove the whistle inhaler works as well as the Medtone. The FDA's agenda is so flawed and corrupt that they penalize those they think they are protecting.

 
MNKD
6.20-0.03(-0.48%)Sep 19 4:15 PMEDT

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