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  • A Realistic MNKD Long-Term Price Target Based On Hard Data About Worldwide Insulin Use [View article]
    People can quibble on some details but this is a nice primer on possible uptake. Good article!
    Jun 24, 2014. 01:55 PM | 5 Likes Like |Link to Comment
  • Arena's Belviq Sales Do More Than Recover [View article]
    Could you comment on what happens with positive results of either the smoking cessation or the BelPhen trials?
    IMO negative results on the smoking trial might blip downwards but nothing is baked in there. IMO negative results on BelPhen would be worse but I really cannot see anything but darn good results on that one.
    Jun 13, 2014. 02:59 PM | 7 Likes Like |Link to Comment
  • Document Security Systems - Patent-Infringement Activity Is Expected To Heat Up In The Next 2 Months [View article]
    Moon, so what kind of reform would you propose? Are you in favor of allowing people to profit off their ideas and inventions at all?
    May 22, 2014. 01:24 PM | 2 Likes Like |Link to Comment
  • MannKind: Forget Earnings, All Eyes On July [View article]
    Two prior CRLs but this time overwhelmingly positive AC votes for both T1 and T2 should allow an approval.

    That plus a partnership announced relatively quickly after approval should give a nice bounce.

    That said, they also said on the CC that they expect it to be approx. 6 months before commercialization starts. That delay, plus the *large* OS count may mute the share price between Sept and Jan.

    It will be interesting to watch. GL to all the longs here.
    May 13, 2014. 12:49 PM | 2 Likes Like |Link to Comment
  • Why I Believe MannKind Shares Will Rise Significantly Upon FDA Approval Of Afrezza [View article]
    Spectro, I'll give you a big amen at this:

    >>Trond-I am looking at Mannkind as an investment with a 5-8 year horizon

    I've been in MNKD (with varying position size) since 2009 so I'm already at year 5 of my personal involvement. I'd LOVE to be a new-to-MNKD investor at this point in time!
    Was in really big prior to the first CRL, took risk off on a goodly portion prior to FDA decision but bought a lot of call options that lost 100%; lost more on the 2nd CRL since I thought they'd ironed everything out; am probably slightly in the green overall right now.

    All that to say, I'm fine with a long time frame. I just am more aware of 2 things: 1) that ramps usually take longer than people think, and 2) price action is never linear.
    Holding a core + trading position works well for me now on these companies that have a great idea/product but need to pass several more risk speedbumps: FDA, partnering, commercialization, market utility.
    IMO we'll get a nice bump on approval, and another on PA. But at THAT point it is a longer process than most probably think to actually get Afrezza sold. Have you looked at several diabetic sites where people are talking about inhaled insulin? A lot appear to be worried about figuring dosing strength and more than *I* thought are less worried about needles than about inhaling a 'new' product. I think it'll be a screaming success, but I see the real ramp happening in 2016-18. And so I will run with my trading position as soon as I have a reasonable profit, and simply keep an eye on the ramp and pipeline until probably mid-2015 or so.

    The absolute best of luck to you and all longs - I hope it is much quicker than I think.
    Apr 11, 2014. 11:17 AM | 2 Likes Like |Link to Comment
  • Why I Believe MannKind Shares Will Rise Significantly Upon FDA Approval Of Afrezza [View article]
    Good response, and I neglected to say it was a fine article. :-)

    To yours and Spectro's (Technosphere and pipeline), yes time will tell.
    I am quite conversant with the pipeline prospects but equally aware that pipeline (cancer especially) requires both large amounts of cash and time/patience. The Technosphere technology is why I have a small core position and will be as patient as I need to be.

    However, and I guess the real point of my reply, is your $24.24 modeled price has no time point associated with it? Is that for the time in between approval+PA but before we have to endure the wait-for-ramp? Or is it "at some point" in the future after we've received approval in Europe too, and have reached peak sales?

    Ramps 'always' take longer than expected in my experience ... heck, with approval in July, we probably will get a PA in late Jul/early Aug, start selling in late Aug, and so the first full Q of earnings will not be until 4Q14, and reported in Feb15 - ten months from now! And then we wait for the next Q to see how growth is shaping up.

    I hate that I sound down on the company, but my overall plan is to take some trading profits after approval, then wait for what I view as an inevitable downdraft to reload. And again, simply based on market cap, I am unwilling to risk much past $14 or so, right after approval/PA. I'd love to be wrong and will be holding my core with those hopes.


    p.s. thanks for the civility vs. my 'negative' opinion
    Apr 10, 2014. 12:50 PM | 5 Likes Like |Link to Comment
  • Why I Believe MannKind Shares Will Rise Significantly Upon FDA Approval Of Afrezza [View article]
    I think the company will get Afrezza approval and a PA. However, I'm not as sanguine about immediate price appreciation past $14 or so.

    There are some issues with using a P/S model for a company with one approved product with the ramp not-yet known, much as the market is future-looking. If you are using peak sales you need to discount back to present day value AND take off a chunk for FDA-risk.

    Your model assumes a PA, but allows for full market revenue ... MNKD will probably get a 15-30% royalty?

    MNKD is quite short on cash and with the FDA delay-of-PDUFA until 7/14, they will either need an understanding partner or another secondary shortly (or more debt to Al which will then be converted to shares).

    Finally, I like to look at market cap for a sanity check. A $14 price tag would be about a $5B cap .... very expensive for a just approved, one-product company with an unknown sales ramp.

    I like MNKD, as unlikely as that probably sounds with the litany I just reeled off. But there are definite headwinds to a $25 SP.

    Apr 10, 2014. 12:12 PM | 7 Likes Like |Link to Comment
  • MannKind's Latest Critic: The FDA Has Joined The Chorus Of Missing Data Concerns [View article]
    Two other people have mentioned the misuse of the term black box.

    This is extremely important to be revised - and I call on the author and SA to immediately pull and re-post this article after editing.

    To use the phrase "black box" wrt the FDA and be speaking simply of an "inconsistency" or "missing data" is .... how to put it nicely? Perhaps examples of the Holocaust or enslavery of ethnic minorities is a bit too strong, but IN TERMS OF THE FDA let's start there.

    A black box warning is the strongest possible FDA warning on a drug label. Life-threatening, even. To throw that phrase out there... let's just say I have my doubts the author is trying to be even-handed in any way here. No way is this an innocent mistake for someone who invests in biotech.
    Mar 31, 2014. 11:39 AM | 13 Likes Like |Link to Comment
  • Marathon Patent Group Continues To Evolve [View article]
    Thanks for the update. Great info.
    Mar 11, 2014. 07:11 PM | Likes Like |Link to Comment
  • Celsion's OPTIMA Study: What You Need To Know [View article]
    I was a huge Celsion bull during 2010-2012. They are now relegated to a sometimes-trading possibility, for me. My primary concern with the new trial is that enrollment will probably extend through 2017. For HEAT, it took 4 years to enroll 600 patients... 550 is not that much fewer and there are even more trials competing for liver cancer patients.
    Feb 26, 2014. 12:04 PM | Likes Like |Link to Comment
  • Response To Ridiculous Claims About NNVC [View instapost]
    Nice rebuttal.
    Feb 14, 2014. 08:20 AM | Likes Like |Link to Comment
  • NanoViricides: House Of Cards With -80% Downside, 'Strong Sell' Recommendation [View article]
    I am actually curious about this issue: when the author mentions BIND as a great contra example.

    I looked up BIND and they switched names and went public less than a year ago. They are already in ph2 for one of their drugs.
    I'd be curious to see what their situation was, when they were preclinical. How much the founders of that company burned through of "the public's" money and how much they extracted?

    Terminator - want to disclose any of that?
    Feb 11, 2014. 12:27 PM | 3 Likes Like |Link to Comment
  • NanoViricides: House Of Cards With -80% Downside, 'Strong Sell' Recommendation [View article]
    I had to laugh at the quote from India New England. This journal evidently said, "The only reason we took it down is the editor is no longer with us and this story caused quite a stir, and we grew tired of all the phone calls"

    I can only imagine how distressing it is for a publication's article to cause a stir. And gosh, having to answer the phone! That must be terrible. Maybe they should cease publishing with that kind of reaction.
    Feb 11, 2014. 12:01 PM | 1 Like Like |Link to Comment
  • AcelRx: Huge Potential With Limited Risk [View article]
    News today of an EU partnership - $30M upfront payment.
    Also PDUFA date assigned of 7/27/14.
    Dec 16, 2013. 12:29 PM | Likes Like |Link to Comment
  • AcelRx: Huge Potential With Limited Risk [View article]
    >> to de-risk a fraction more, it might be good for new money to wait until the FDA accepts the NDA (should be any day now)

    Two business days later... :-)
    Dec 2, 2013. 01:57 PM | Likes Like |Link to Comment