FDA panel recommends approving MannKind's Afrezza

The FDA's advisory committee voted 13-1 to recommend Afrezza be given marketing approval for treating type 1 diabetes, and 14-0 for treating type 2 diabetes. The PDUFA date for the FDA to complete its review of Afrezza is set for April 15.

MannKind (MNKD) shares were halted all day, and remain halted AH. The company notes Afrezza, if approved, would be "the first ultra rapid-acting mealtime insulin therapy available in the United States."

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Comments (20)
  • john12310
    , contributor
    Comments (74) | Send Message
    Shorts, bend over. You played with us longs, now it's our turn.
    Mnkd kept all marketing rights. To the moon Alice.
    1 Apr 2014, 06:40 PM Reply Like
  • pilot fish
    , contributor
    Comments (147) | Send Message
    Amen. Sick of the manipulation, and hope people who have INVESTED in this company are rewarded. Long and holding here!
    1 Apr 2014, 07:53 PM Reply Like
  • mike ekim
    , contributor
    Comments (407) | Send Message
    roger that john :)
    2 Apr 2014, 02:17 AM Reply Like
  • dnbuff
    , contributor
    Comments (3) | Send Message
    It was shameful how bad the shorts manipulated the market this last week for what turned out to be an absolute slam dunk--this approval vote wasn't even close.
    2 Apr 2014, 02:27 AM Reply Like
  • nikeherc1
    , contributor
    Comments (44) | Send Message
    To quote Shaq, CAN YOU DIGG IT!!!!!!!! Shorts you can't cover fast enough…
    It is on all the local news shows in Los Angeles.
    1 Apr 2014, 08:46 PM Reply Like
  • john12310
    , contributor
    Comments (74) | Send Message
    With all marking rights in house, this could be 100.00$ stock in five years.
    Longs hold on the best is yet to come.
    1 Apr 2014, 08:54 PM Reply Like
  • Burrben
    , contributor
    Comments (8) | Send Message
    When will MNKD open for trading? Premarket or 9.30?
    Crazy to put in a market order during opening rotation to buy?
    Or a market order to buy some 6$ calls?
    Can't use limts as I have no idea what the price will be.
    1 Apr 2014, 09:27 PM Reply Like
  • pgilgan
    , contributor
    Comments (12) | Send Message
    What big Pharma will want to partner?? Wonder if one is already committed.
    1 Apr 2014, 09:38 PM Reply Like
  • PengieP
    , contributor
    Comments (109) | Send Message
    I'm just guessing that MNKD has a deal with Novo Nordisk in the wings upon FDA approval.
    2 Apr 2014, 09:11 AM Reply Like
  • xray67
    , contributor
    Comments (21) | Send Message
    As I noted elsewhere on SA, most of the disastrous debilitating effects of diabetes (blindness, kidney failure, neuropathies, etc.) all basically stem from asynchronous swings in insulin and blood glucose levels. These swings are obviously not well controlled with current therapy, ergo the progression to the downstream effects. The convenient (who wants to shoot up in a restaurant?), fast acting AFREZZA package could really change this situation. The FDA got this one right.
    1 Apr 2014, 10:04 PM Reply Like
  • slowbullet
    , contributor
    Comments (8) | Send Message


    Becarefull...short covering will lead to near term jump in stock price so don't buy in to fast if you are truly long. Okay to take some profit at this time.
    2 Apr 2014, 12:04 AM Reply Like
  • linleon
    , contributor
    Comments (5) | Send Message
    From all of us, I would like to express my deepest gratitude to George Rho, Jeff Eiseman, Ben Yoffe, Greg Johnstone and many others who provided intelligent and honest analysis of the facts during this very difficult and frustrating time for longs. Thank You!
    2 Apr 2014, 01:26 AM Reply Like
  • guicanuel
    , contributor
    Comments (2) | Send Message
    Glad I kept it! Will love to see how it goes tomorrow ;)
    2 Apr 2014, 02:28 AM Reply Like
  • jimwriter
    , contributor
    Comments (2) | Send Message
    I held firm even as the stock plummeted. After being burned many times, finally, this looks like a good bet.
    2 Apr 2014, 02:38 AM Reply Like
  • 9767081
    , contributor
    Comments (12) | Send Message
    Finally some encouraging news. I'll keep my fingers crossed until the final decision April 15th. I've learned not to count my chickens before they cross the road. Ha!
    2 Apr 2014, 02:38 AM Reply Like
  • MrMcchumba
    , contributor
    Comments (17) | Send Message
    Special thanks to George Rho, Jeff Eiseman, Greg Johnson, Tri Duong, Balert2, and the many other SA members who took the time to provide calm, logical, informed opinions. I have 100k shares that I ALMOST sold in a panic a few days ago. Thank you gentleman. Long MNKD!
    2 Apr 2014, 08:54 AM Reply Like
  • circleville5
    , contributor
    Comments (4) | Send Message
    will resume trading @ 6:15
    2 Apr 2014, 10:16 AM Reply Like
  • StevieBearcat
    , contributor
    Comments (4) | Send Message
    I am 10 years long with 30% of my retirement. God Bless Mr Mann for hanging in there forgood of Humanity.
    2 Apr 2014, 10:24 AM Reply Like
  • MichaelJ8
    , contributor
    Comments (880) | Send Message
    actaully,, very underwhelmed with the move here.
    2 Apr 2014, 04:43 PM Reply Like
  • john12310
    , contributor
    Comments (74) | Send Message
    For those who follow Cramer, I don't agree with selling half. 1 this plays into
    The short covering. 2 most important this is just the start of a long and profitable
    Run. We have weathered the worse, now enjoy the profit party. Having said this,
    Today's volume probable means lots shorts have covered. Good luck to all.
    2 Apr 2014, 11:31 PM Reply Like
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