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  • Will The Third Time Be A Charm For MannKind? Leading Fund Managers Definitely Think So [View article]
    I'm pretty jaded regarding MNKD, but this is a great article. You show how this is not a "home run", but an investment with both risk and opportunity, and lay out signals showing a positive risk / reward ratio.

    Thanks for keeping it real, if unashamedly bullish. The article is straight-forward and logical.
    Apr 6, 2014. 08:57 AM | 3 Likes Like |Link to Comment
  • MannKind: Follow The Smart Money [View article]
    Hi Mr Rho

    Thank you for your polite and open reply.

    I would not have thought that you were deliberately misleading readers, but the pediatric testing issue is an easy one to get mixed up, especially since it seems to be common wisdom that asking for testing = saying that the drug must be safe for those clinical subjects. (That, of course, is not the case).

    The content I refer to comes from your January 2014 article "MannKind's Day Of Reckoning Is Getting Very Close"

    "In our view, the FDA's yes or no decision on Afrezza was essentially made three years ago...[content snipped for brevity] ...Beyond helping design the so-called Affinity studies, the FDA has asked MannKind to conduct post-marketing studies in children as young as four years old. This clearly suggests the agency has little concern about the drug's safety."

    The requirement for post-marketing studies in fact gives no indication of the FDA's concern for safety. They are simply enforcing policy. In order to sell to children, a company must first test on children. If a sponsor company is unwilling to take that risk or expense then they will not be able to sell to children.

    A waiver, allowing MNKD to market Afrezza to children post-approval without pediatric trials would have been the clear indication that the FDA has no safety concerns in children. They did not do that.

    Once again, best regards and good luck.
    Mar 25, 2014. 10:35 AM | 1 Like Like |Link to Comment
  • MannKind: Follow The Smart Money [View article]
    Mr Rho

    You obviously continue to put a lot of energy and time into your communication of the investment opportunity of several companies, and your track record speaks for itself.

    You may, however, want to revisit your position on pediatric testing and MNKD. As has been mentioned by many others, pediatric testing is not a sign of support by the FDA, but is expected if a sponsor wants the label to indicate pediatric use. No testing, no pediatric use.

    You claim that the FDA requesting testing down to 4 yrs of age is a vote of confidence in Afrezza. Simply not so. The facts:

    1. Mannkind has requested a deferral of pediatric testing, and has been granted one until post-commercialization. Children will be excluded from the label. If the FDA was confident in Afrezza's safety in pediatric populations, they would have been granted a waiver allowing immediate marketing to children post-approval. Instead, pediatric use is now years in the future.

    2. Mannkind suggested post-commercialization testing on children down to 12 years of age. The FDA responded with a request for the testing to include age groups down to 4 years old, not cutting MNKD any slack on the testing requirement.

    I'm sure that you know the requirements and FDA guidance for pediatric testing. The much-repeated (including by you) "FDA must think Afrezza is safe if they want it used on 4-year-olds" line is a distortion of fact, and is better framed as "children will not be indicated on the label until safety and efficacy is proven for children."

    Please do not continue to be part of the group spreading this incorrect interpretation.

    That said, I wish you good fortune over the coming months.
    Mar 25, 2014. 08:47 AM | 2 Likes Like |Link to Comment
  • Fear, Greed, And Prudent Risks: A Clarion Call To The Keepers Of The MannKind Flame [View article]
    So, in a nutshell:

    "Some people believe that MNKD is a risky investment. Invest anyway."

    Good article.
    Mar 24, 2014. 03:52 PM | 2 Likes Like |Link to Comment
  • MannKind Fair Share Price $50 Or $150? [View instapost]
    You sound like a decent guy. Thanks for the polite reply to my less-than-polite (if realistic) comment.

    I was mostly trying to poke at the $50 - $150 valuation. It really is an unlikely price target, given the state of MNKD's balance sheet.

    Here's a reasonable source for basal / prandial / premix market share: slide 27

    Baslal 47.8%
    Prandial 33.9%
    Pre-mix 18.3%

    Also, the anti-diabetic drug market is highly segmented. Mannkind would do well to crack 5%-10% of this market in the first several years since there's so much competition. A 5% market penetration would qualify Afrezza as a blockbuster.

    Best of luck to you and your family members.

    Disclosure: I'm long, hedged, excited for the next 2 weeks.
    Mar 24, 2014. 07:21 AM | Likes Like |Link to Comment
  • MannKind Fair Share Price $50 Or $150? [View instapost]
    "If approved, Afrezza will dominate this market."

    Wow! 75% of the insulin market? That, my friend, is baseless crass speculation.

    It would be an interesting feat, since 50% of the insulin market is for basal insulin, which Afrezza does not replace.

    So, I guess Afrezza will have to take 150% of the prandial market.
    Mar 23, 2014. 04:54 PM | Likes Like |Link to Comment
  • Prana Biotechnology And MannKind Corp.: Bad News Obeys Its Own Special Laws [View article]
    Yes, I do indeed mean March 28. Thanks, my typo.
    Feb 25, 2014. 04:41 PM | Likes Like |Link to Comment
  • Prana Biotechnology And MannKind Corp.: Bad News Obeys Its Own Special Laws [View article]
    A couple of questions for those titillated or enrsged by this article:

    Ask yourself "are endpoints often moved without explanation in confirmatory trials?"

    Ask yourself "is a net .4% HbA1c benefit of real clinical utility?"

    Ask yourself "as an investor, do I want to know all the results or some of the results going into approval?" Because the FDA has all of the results, and all of the raw data.

    Ask yourself "If Afrezza represents a new paradigm, will physicians change their paradigm? Think of the Apple Newton. Flop. Think of the Palm Pilot - huge success. Was Exhubera the Newton? Will Afrezza be the Palm pilot? Who knows, but this is what long investors are hoping for.

    If I had one recommendation for people: only hold across May 28 - April 16 what you can afford to lose without any emotion. Don't go all-in on a binary play. Or at least have some kind of protection. Remember the 2nd CRL - crazy things can happen at the 11th hour. Then again; no risk no reward.
    Feb 20, 2014. 12:58 PM | 3 Likes Like |Link to Comment