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MannKind Corp. Message Board

  • dreidel_boy dreidel_boy Aug 16, 2013 7:11 PM Flag

    "In business, If you hesitate, you are lost"

    is the immediate aphorism that comes to mind for decision to wait unti 4Q to file FDA. shows a bit of lack of confidence in the outcome, but i hope that I am wrong

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    • It takes more than 3 months to prepare NDA Filing. You are dealing with FDA and will not want to hear from it this is missing, that is unclear, etc. etc. etc. Q4 filing is reasonable and has nothing to do with confidence.

      PPS is not related to the timing of the filing. The volatility will not end until the end of Q3. See the option expiration dates, today, 08/23, 08/30, 09/06, 09/13, 09/20. #$%$, PPS will move drastically. I will not be surprised that PPS will touch $9 again within a week or two.

      Sentiment: Strong Buy

    • You're crazy. They said they're filing in early October! That's less than 2 months away. That is NOT waiting. That's FAST to file a new NDA. Never seen it faster by anyone.

      Sentiment: Strong Buy

    • I doubt they are "waiting". It takes time to analyze al the data. Sometimes one finding begets more questions which then require further analysis. There are lots of variables to examine and many ways of cutting the data. Conclusions need to be drawn and interpretation of the data agreed upon. Then it all needs to be put in the proper format before submitted. 4th Quarter is only 6 weeks away. Relax.

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