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Over 25 years individual investment experience in stocks, bonds, options, and Forex trading. I have developed my own model to find out of favor stocks, stocks with high short interest, and developing technologies for high value investment opportunities. Bachelor of Arts, Criminal Justice:... More
  • The Future Of MannKind: Reach For The Technosphere 18 comments
    Feb 24, 2014 9:20 AM | about stocks: MNKD

    On April 1, 2014, the much awaited ADCOM event for MannKind's Afrezza will be discussed with an FDA advisory committee. Many investors are entirely aware of the impact the resulting vote of this committee will have on MannKind's (NASDAQ:MNKD) future. This particular vote is important, because on April 15th, the FDA will render a much awaited decision on Afrezza. The FDA is not obligated to approve any drug, based soley on an advisory panel's vote, but they normally do vote in the same manner. Investors should be looking for the March 28th release of the FDA's briefing documents just a couple days earlier. These documents should give some indication as to what the FDA is thinking.

    Previous history of approval for Afrezza has not been too 'Kind. However, after 2 CRL's and further sets of clinical trials, and several years later, MannKind is laying it all on the line. Recent conference calls express the company's vision that the FDA will finally give the nod and Afrezza will finally come to market. The company is burning through millions of dollars to ramp up production faciliies to meet demand in a $40+ Billion market. Analysts are now viewing the diabetic market at $32 Billion by 2018. But, the Technosphere platform, if approved, would have the company reaching for the stratosphere. In fact, in 2010, two of their facilities recieved Facility of the Year Awards. See www.news.mannkindcorp.com/phoenix.zhtml?...;highlight=

    Interestingly enough, there is tons of data on the street about the Technosphere insulin platform, from the previous trials, that is availabe for patients, doctors, and potential investors alike. One that I would like to share is very interesting and chock full of great information. It can be viewed at formularyjournal.modernmedicine.com/form...-

    The Technosphere platform likely has Big Pharma companies, that are deeply involved in the Diabetes market with needles, either ready to inject themselves these days, or be ready to pounce on a takeover of MannKind.

    The most important thing for investors to understand now, is that, should Afrezza be approved by the FDA on April 15th, the Technosphere platform has unlimited potential in the medical community. It's reach would extend well beyond just diabetic medication use. Thus, the Technosphere platform is a complete game changer, and one the Big Pharma companies will be most interested in going forward.

    It is my opinion that the value of the company lies in the Technosphere platform. And while Afrezza is the first stepping stone in MannKind's future, and a big one, FDA approval opens a whole new plethora of possibilities for "Mankind" and "MannKind." With previous failed attempts, and a couple CRL'S (Complete Response Letter) from the FDA in past years, one has to fully believe that the company is now ready for approval. Otherwise, I believe the FDA would have long ago outright rejected the platform and any future attempts to get Afrezza, or any other drug, to market using these methods. The clinical data shows its safety, efficacy, and even attributes to some weight loss under some circumstances. The clinical data also shows the even distribution of medication through the lungs. The data also shows there are no pulmonary issues.

    Personally, I expect MannKind will receive FDA approval on April 15th this time around, and not only will investors cheer, but so will doctors and patients around the world. Let's face it, needles are out, and the time for newer technology is in. Big Pharma companies will have to get on board, or get left behind.

    I believe the FDA has a responsibility to look to what patients are asking for when technological platforms like Technosphere are available, and as long as they are safe and effective, they should not keep them from patients. Every diabetic patient I have had the pleasure to know, always hated the needles, and always had to go hide somewhere in embarrassment to take an injection. Our world is better than that. I beleive MannKind has worked hard over the years, working with the FDA consistently, to prove their platform works and is the future. The next time a person needs to take their insulin, they should not be reaching for a needle. They should be reaching for the Technosphere.........and I believe they will.

    Disclosure: I am long MNKD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Themes: long-ideas Stocks: MNKD
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Comments (18)
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  • kevinmik
    , contributor
    Comments (26) | Send Message
     
    Great article and thanks for focusing on the real potential of this game changing technology.
    24 Feb, 09:46 PM Reply Like
  • Think Long Term
    , contributor
    Comments (119) | Send Message
     
    Author’s reply » Thanks.

     

    Seems that the formulary journal website was cut off for some reason, It is:

     

    http://bit.ly/1bHtmw7-

     

    Just search it in google: formulary journal technosphere insulin

     

    It is loaded with great research information for those interested.
    24 Feb, 10:17 PM Reply Like
  • statdrugs
    , contributor
    Comments (29) | Send Message
     
    Good non bias information. I agree with you opinion. Thanks for your contribution.
    24 Feb, 10:32 PM Reply Like
  • Butchmass
    , contributor
    Comments (2) | Send Message
     
    I just hope that Afreeza gets approved. My grandson is a diabetic and this would really help to make things easier on him. Him as well as all the other diabetics in the world. Pray for approval for the sake of mankind.
    24 Feb, 10:41 PM Reply Like
  • robdoc
    , contributor
    Comments (105) | Send Message
     
    Afrezza not Afreeza.
    The Technosphere platform is potentially unlimited.
    24 Feb, 11:01 PM Reply Like
  • Think Long Term
    , contributor
    Comments (119) | Send Message
     
    Author’s reply » Spelling corrected. Thank you for correcting my misspelling.
    25 Feb, 01:15 AM Reply Like
  • gamblerjag
    , contributor
    Comments (90) | Send Message
     
    not a diabetic.. but never understood why anyone would be embarrassed to do an injection.. inconvenient yes.. but embarrassed.. it's not like people are going to think they are injecting heroin... however in saying this... Afreeza will be a game changer.
    24 Feb, 11:04 PM Reply Like
  • in4thelonghaul
    , contributor
    Comments (240) | Send Message
     
    After demonstrating over and over and over Afrezza's superior safety and efficacy profiles, not to mention the likely very significant positive impact on compliance, especially for the young and newly insulin dependent (my supposition here), MNKD once again finds itself before the FDA. Afrezza should have been approved years ago, but hopefully this time the FDA will actually do the right thing for the world's diabetics. It is my contention, and I think the evidence clearly indicates as much, that Afrezza will actually not just increase quality of life and overall health through superior glucose control (read that as saving society vast sums on health care which will now NOT be needed), but actually save lives by effectively decreasing the incidence of severe low blood glucose episodes (hypoglycemic shock) among those who switch over to Afrezza. One could, I guess, extrapolate that the 'unavailability' of Afrezza for the last couple of years has actually cost lives - but then what is done is done. Such a shame that we are all holding our breath, hoping the FDA will actually do the right thing and approve what is clearly a safer and superior treatment.
    24 Feb, 11:22 PM Reply Like
  • MrHaigs
    , contributor
    Comments (102) | Send Message
     
    "Afrezza" not "Afreeza". I agree with your points, but you gotta spell the name of the drug correctly. COME ON MAN.
    24 Feb, 11:51 PM Reply Like
  • Think Long Term
    , contributor
    Comments (119) | Send Message
     
    Author’s reply » corrected. Thanks.
    25 Feb, 01:16 AM Reply Like
  • Manoj Madhavan
    , contributor
    Comments (70) | Send Message
     
    I agree with your points. Technosphere has the potential to be much bigger than Afrezza.

     

    I am long MNKD but I think MNKD will be a super strong long term buy two or three days after FDA approval.
    25 Feb, 09:01 AM Reply Like
  • freedom_has_few_friends
    , contributor
    Comments (33) | Send Message
     
    To me, the largest question remaining is: if Afrezza is destined to be commercially successful, why hasn't MannKind acquired a partner yet?

     

    I'm hoping, and somewhat believing, the answer is that the big pharma companies are acting in an overly cautionary manner due to the Exubera debacle.
    25 Feb, 10:22 AM Reply Like
  • Manoj Madhavan
    , contributor
    Comments (70) | Send Message
     
    freedom_has_few_friends - Another reason (in my opinion) is that Al Mann has invested many years of his life and a few billion dollars of his own money in this company. He is asking for a lot more than what Big pharma is willing to give at this point.
    All this will change if the FDA approves Afrezza this year (maybe by April 15 maybe later).
    25 Feb, 10:41 AM Reply Like
  • EHSTEINERT
    , contributor
    Comments (50) | Send Message
     
    One thing that concerns me and that all MNKD investors should follow closely: the roster of voting members for the 4/1 AdCom. There is one standing member named Dr. Mads Rasmussen. He has been serving as a non-voting "industry representative," and is the Executive Director, Clinical Development and Research, Diabetes Clinical Development, Medical and Regulatory Affairs...

     

    for Novo Nordisk Inc.

     

    One of Novo Nordisk's most important markets is diabetes treatment. THEY MAKE INSULIN PENS. MannKind is using insulin pen pricing as their model for Afrezza pricing. If Afrezza is approved, insulin pens will be the first products impacted by MannKind's Dreamboat delivery system.

     

    Dr. Rasmussen has about as extreme a conflict of interest with Afrezza as you could possibly construct. Yes, his status has been non-voting as recently as December's committee meeting. But there is a waiver system in place at the FDA to grant voting status to committee members with conflicts. In theory it is very rigid process, but we have seen dark forces at work in the past regarding the Afrezza approval process.

     

    I'm watching this very closely and so should you. It's bad enough that Dr. Rasmussen will be in the same room as the committee meeting. If suddenly he is waivered to voting status you can bet something is going on behind the curtain.

     

    Afrezza represents a huge threat to the existing diabetes products market. $$billions are at stake, and I don't put anything past Big Pharma's/Wall Street's vested interests.

     

    GLTAL
    25 Feb, 11:39 AM Reply Like
  • Think Long Term
    , contributor
    Comments (119) | Send Message
     
    Author’s reply » In response, I will say the one voting member is not going to decide the fate of the entire vote. Now, I agree that if he persuades other voters to vote no, it could turn the vote. However, I believe the data is too strong to ignore, and anything but an ADCOM approval vote would certainly raise some eyebrows. Last time this happened in the vote, a couple of folks ended up in jail. I don't think anyone is going to risk that.
    25 Feb, 10:22 PM Reply Like
  • EHSTEINERT
    , contributor
    Comments (50) | Send Message
     
    In general I am more comfortable in this case because, as you say, lights have been turned on. But don't lose site of the real thrust of my concern, that being Rasmussen getting a waiver to vote. IF that happens, it needs to be challenged by the public (there is a procedure to do this). I can tell you this is on MannKind's radar too.
    26 Feb, 02:57 PM Reply Like
  • freedom_has_few_friends
    , contributor
    Comments (33) | Send Message
     
    Interesting comments by EHSTEINERT. If something like this goes down, MannKind and its shareholders should be looking for attorneys, and so should the diabetics who can benefit from Afrezza. There was a time when I wasn't sure this could happen, but with the increasing coziness between Big Business and Big Government, I too can't put anything out of the realm of possible.
    25 Feb, 01:33 PM Reply Like
  • Think Long Term
    , contributor
    Comments (119) | Send Message
     
    Author’s reply » New Short Interest out today. Standing now at 58.12 Million shares short. Are the shorts being led to the slaughter? Just maybe, Al Mann withheld some data because he knew the shorts would pile on like they have, as they do with all small bio's, and then crush them hard? Al is a very wise, old businessman who has been around the block in the markets. If I were a short, I would be very afraid come April 1st, because they will already be demolished by the time an April 15th approval decision arrived. Definitely something to think about.
    26 Feb, 08:41 PM Reply Like
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