MannKind announces Ad Com date, shares stumble

MannKind Pharmaceuticals (MNKD) trades lower by 11% in premarket action.

The company says an Afrezza Ad Com has been tentatively scheduled for April 1.

Also not helping matters is The Street's Adam Feuerstein, who had the following to say today about the inhaled insulin product's chances for approval: "The results from the two phase 3 studies announced this summer were barely passable [and] we still don't know, exactly, how the current 'Dreamboat' inhaler performed relative to the older Medtone inhaler."

"None of the Afrezza data have been presented at a medical meeting or published," Feuerstein notes, adding that while he "absolutely" could be wrong about the drug's chances, "there's certainly precedent for an Afrezza rejection. Two, actually."

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Comments (14)
  • 3D Investing
    , contributor
    Comments (1552) | Send Message
    Adam F. at his best. How does this guy still have a job?
    10 Jan 2014, 09:27 AM Reply Like
  • MorrisSean
    , contributor
    Comments (103) | Send Message
    They probably don't pay him over at The Street. He makes a percentage from the shorts...


    Seriously people, read his articles on Mannkind before selling. He doesn't even do his own research just quotes someone else and brings up old irrelevant information.


    Regarding the device comparison. Mannkind did exactly what the FDA asked for (in the last clinical trials)...and they met the primary end points. But, you the Mannkind investor should already know this...


    If you didn't, you shouldn't be investing in MNKD. And, if you follow Adams advice on anything (without doing your own research) you should not be in stocks..seriously buy an ETF.


    FYI: the real reason for the pullback was because the stock was overextended technically. I expect the MNKD to be between $8 to $10 by April 1st.


    Long MNKD


    This is a message to the general public not a specific comment to a post.
    10 Jan 2014, 10:35 AM Reply Like
  • vanebfbc
    , contributor
    Comments (160) | Send Message
    Feuerstein is known to short almost all biotech stocks. He was right sometimes, like $ZLCS. But most of his calls were wrong, and yet he makes a fortune from panic selling almost every time he says something. Don't believe everything he says. We should do our own DD, and make volatility our friend.
    10 Jan 2014, 10:41 AM Reply Like
  • Jeb Walport
    , contributor
    Comments (951) | Send Message
    By making churning up circumstances to favor the Shorts .....
    10 Jan 2014, 09:54 AM Reply Like
  • joel steve
    , contributor
    Comments (38) | Send Message
    In other words-1+1 = 3.... Most of the time . Except sometimes it equals 2 . I could be wrong though. Somebody once told me the answer was 4. Ya' know?
    10 Jan 2014, 09:58 AM Reply Like
  • johnnyaction
    , contributor
    Comments (4) | Send Message
    Retail investor. Does MNKD have a partner for Afrezza?
    10 Jan 2014, 10:29 AM Reply Like
  • Andrew Colburn
    , contributor
    Comments (139) | Send Message
    No, not yet. Partnering before approval of the product would result in a lower bargaining chip and a lower % of revenue.
    10 Jan 2014, 10:45 AM Reply Like
  • bbraxton
    , contributor
    Comments (90) | Send Message
    This guy still is not giving the facts. the rejection by the FDA was not because of Afreeza. It was because of the switch to a new inhaler. Also even if it proves equal to inject-able in end. I am sure a huge majority of people would switch the the inhaled insulin. Did he even read the circumstances under which it was rejected the first time? No because if he did it appears like some one thought it was going to be approved and thus brought a lot of stock. Only to have it not approved by the FDA. But I guess the guy would not have a job if he did not have to say something to go against what is going to be a huge money maker in the insulin arena. One more thing the guy behind inhaled insulin has had way to many the insulin pump, cgm and etc.
    10 Jan 2014, 10:30 AM Reply Like
  • MichaelJ8
    , contributor
    Comments (869) | Send Message
    Yeah, Adam F is not credible imo. I don't listen to him. Notice how mnkd is still up about 4% over the past 2 days... He puts this out right after a big day... perfect timing...


    notice hes says results are barely passable.... which if you know something about statistics doesn't matter. If it passes its significant, there is no barely.


    Also, its a spec biotech.... its almost always 50/50 chance. the point is MNKD potential sales and market cap is huge, and thereby worth the bet. Going short maxes at 100% profit, going long maxes at infinite profit.
    10 Jan 2014, 03:22 PM Reply Like
  • etienne79
    , contributor
    Comments (60) | Send Message
    Shame on SA reporting such gross and obviously biased comment from an irrelevant short.I'd like to read about facts and real news, not about the trash opinion of a short that does not even understand the aim of the last Affinity 1 and 2 studies.. At this point, why didn't you SA even publish the funny last part about supposed "persistent cough"? You even linked the page as if it's something worth a glance.. please, be more objective for the sake of your professionalism.
    10 Jan 2014, 04:44 PM Reply Like
  • libouban
    , contributor
    Comments (142) | Send Message
    AF does not have much credibility. He seems to provide poorly argumented opinions. To me, a positive FDA decision would be the last nail. I would then completely ignore his positions.
    When comparing SA factual articles and AF's 30 seconds claims, I must say AF does not come out on top.
    12 Jan 2014, 09:13 PM Reply Like
  • NHPeter50
    , contributor
    Comments (2) | Send Message
    I'm fairly new at this game, however the action of the stock today was fairly predictable. There was a gap left between the close of 1/8/14 close $5.985 and the strong open of 1/9/14 $6.02. From what I've learned, most stocks close their gaps. Thank God today at the close they finally closed that gap. It took 4 attempts. Put up a traders chart 10/10 and you will see I had a long day waiting for that close. Let's see what Monday brings.I live in NH and I hope it's not snow. It's fun reading your comments, I hope you all have a good weekend.


    12 Jan 2014, 09:24 PM Reply Like
  • Welt
    , contributor
    Comments (252) | Send Message
    Gaps have a way of filling sometimes, but this is not always the case. Saying that MNKD's action was "fairly predictable" is far from the truth. If it were that easy everyone would be rich. Stocks continue higher never filling small, and even large, gaps everyday.


    With that said, trading on gaps is better than trading on nothing. Good luck
    12 Jan 2014, 10:01 PM Reply Like
  • godwinpeak
    , contributor
    Comments (75) | Send Message
    During today's conference call, Al Mann, apparently taking aim at Feuerstein's negative remark that all Affrezza test data has yet to be released, explained why as follows:


    "After the advisory committee meeting, the next major occasion to talk in detail about the clinical potential, which today is exclusive, only with AFREZZA, will be the annual meeting of the American Diabetes Association.


    That ADA session will be the first scientific meeting at which we will publicly present the full data from our recent Phase III studies, MKC-171 and 175. I know some investors had wanted earlier disclosure of the complete results of those pivotal trials, but in order to reserve the opportunity to present novel results at a major scientific meeting and to publish the studies in a peer reviewed journal, it is necessary that we comply with the editorial policies of those organizations, which do not accept for presentation or publication any previously disclosed research findings."
    18 Feb 2014, 09:15 PM Reply Like
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