MannKind down premarket

Shares of MannKind Corp. (MNKD) are down 18% before the open on mediocre volume in response to the FDA extending its AFREZZA PDUFA date three months to July 15.

The company says the agency needs the time to review the information it submitted in response to its requests.

This should not be surprising since the Ad Comm meeting was only a week ago.

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Comments (16)
  • pilot fish
    , contributor
    Comments (147) | Send Message
    Just in time to let the shorts cover. Conveniently for some. I'm long and am not surprised.
    7 Apr 2014, 07:19 AM Reply Like
  • gmanwicksy
    , contributor
    Comments (131) | Send Message
    Its toast, they are going to hammer it. FDA never liked it and will kill it now, otherwise why wouldn't they have approved it? For the record I never thought it would make it, too many negatives, there to see if you take off your rose colored glasses.
    7 Apr 2014, 07:20 AM Reply Like
  • just read the instructions
    , contributor
    Comments (776) | Send Message
    Exuberant aggressive wording. How comes? Nobody's your enemy here.
    7 Apr 2014, 07:35 AM Reply Like
  • pcaflisch
    , contributor
    Comments (263) | Send Message
    just read....perfect reply...just what I was thinking......just love know it alls who publicly pat themselves on the back.....pathetic
    7 Apr 2014, 07:47 AM Reply Like
  • 3D Investing
    , contributor
    Comments (1552) | Send Message
    Looks like a good time to cover your short or add to your position.
    7 Apr 2014, 07:57 AM Reply Like
  • gmanwicksy
    , contributor
    Comments (131) | Send Message
    Sorry Tri your going to have to wait to buy that new car. Take your shares and run to another stock that can help you avoid losses.


    I think the fda may take the 3 months to hammer mnkd with a new trial to prove the hypoglycemia advantage they pushed on the panel last week. Either that, and/or the very costly post studies on lung cancer that need to be set up in addition to warnings that need to be included. FDA has lots of work to do and so yet does mknd. Let the dilution begin.
    7 Apr 2014, 08:10 AM Reply Like
  • 3D Investing
    , contributor
    Comments (1552) | Send Message
    I can buy a new car any time I want. My Infiniti is working great so there's no need.


    Opinions are worthless without anything to support your claims. At the very least, cite your source where the FDA rejected drugs with long term lung cancer concerns.


    I have high doubt you've actually watched the ADCOM from what you're saying here.


    Good luck. I'll hold my position for the big pay off. I predicted by T1 and T2 approval for ADCOM and it came out exactly like I stated because I've actually bothered to read all the documentations before throwing my 2 cents around. Even the most dedicated longs didn't see T1 coming. As always, I put my money where my mouth is.


    Good luck to you and your investment.
    7 Apr 2014, 08:42 AM Reply Like
  • rambler1
    , contributor
    Comments (1024) | Send Message
    Judging by the stock apparently it was a surprise.
    7 Apr 2014, 08:11 AM Reply Like
  • Yrubinek
    , contributor
    Comments (398) | Send Message
    What is another 3 months compare 10 years of development to Al.Mann.


    7 Apr 2014, 08:23 AM Reply Like
  • Keith_69
    , contributor
    Comments (177) | Send Message
    Well this is certainly not the end, but it is going to make for a bumpy ride where smooth air seemed ahead. :) See if I can make some money on the dip. I am still long $MNKD but love a chance to pick up some money.
    7 Apr 2014, 09:40 AM Reply Like
  • ob doc
    , contributor
    Comments (4) | Send Message
    Awesome news. Time to use the knee jerk reaction to buy more #MNKD. No matter how long it'll take this is a 11 dollar stock with FDA approval, and the FDA almost NEVER go against Ad Com voting. I'm putting in premarket order for 6 bucks now.
    7 Apr 2014, 10:04 AM Reply Like
  • losbronces
    , contributor
    Comments (1007) | Send Message
    Kills my strangle though. Big loss on both legs.
    7 Apr 2014, 10:05 AM Reply Like
  • MichaelJ8
    , contributor
    Comments (881) | Send Message
    Yeap.... took a gamble.. paid the price... thats the government
    7 Apr 2014, 11:47 AM Reply Like
  • User 15536532
    , contributor
    Comments (96) | Send Message
    Personally, I think FDA does approve Afrezza and it will be a good thing for diabetics.....but I think negative rumors bring this stock back under $2 before the final approval (which may not be in July... FDA may draw this out even further.)


    It will probably be a long painful ride. Once it's on the market, I could see other companies trying to license the technology for drug delivery. In my opinion, MNKD will be a valuable investment in the future, but I am waiting before starting any positions.
    7 Apr 2014, 11:18 AM Reply Like
  • panchosfc
    , contributor
    Comments (44) | Send Message
    When the FDA will approve it? May or June???
    7 Apr 2014, 12:14 PM Reply Like
  • marks2522
    , contributor
    Comments (2) | Send Message
    Time to let options expire and re up to July.
    7 Apr 2014, 12:17 PM Reply Like
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