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  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC [View article]
    GGG ~

    Something I should have mentioned but didn't. I remember Bob, from Bob on Stocks mentioning the Cubist acquisition idea as the recently approved Durata product challenges one of their recently acquired products, yes?

    Just be sure that Cubist doesn't take the alternative road of trying to drive Durata into the ground commercially. This doesn't mean that Durata won't be bought out by someone else - a Cubist competitor, but this notion - along with the terrible biotech market as a whole, might account for Durata's lowly price gains after approval.

    Unless AstraZeneca for instance, thinks that naloxegol isn't the revenue genie they once imagined it to be and tanks the adcom on purpose - a thought which has run across my sordid mind, then they will come out guns a blazing commercially to drive any Cubist product now in clinical trials into the ground. And they have the wherewithal to do it.

    Cubist might be thinking along those same lines where Durata is concerned.

    If it occurs to you that I have no idea what I'm talking about, it's because you're right, I don't!

    I think the Cougar Crest Cabernet is talking now...

    Michael
    Apr 21 05:48 AM | Likes Like |Link to Comment
  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC [View article]
    Rick, I want to thank you, both for the vote of confidence and for the opportunity to include something I ought not to have left out.

    What people don't see, is that a positive outcome will have more than a catalyzing effect on the stock price - macro concerns aside, but in very real terms will leave Nektar in a never before experienced position as a biotech.

    Consider, if you will, that Nektar will end 2014 with over half a billion dollars in cash - royalty payments from Baxter and others not included. That represents a year over year revenue increase of 300%. This will be reported concurrent to the receipt of NKTR-102 top line data in early 2015.

    Think the price of shares will rocket upward on those two dates?

    Always be well...

    Michael
    Apr 21 05:27 AM | 1 Like Like |Link to Comment
  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC [View article]
    crimsonbey ~

    You're worth the effort. This is the best I could come up with.

    Here's David Mazzo, Regado's CEO at the Q4 2013 Earnings Call

    "Importantly, this year, we expect to have three interim analysis for the REGULATE-PCI trial, the first of which will come after 1,000 patients and it’s approaching very, very quickly within a predicting, a very early second quarter announcement of that result. And we remain comfortably on track for that.

    If you recall, this trial began in enzyme negative patients and at the 1,000 patient market after a DSMB analysis we will open the trial up to all partners which would include the enzyme positive or NSTEMI ACS PCI patients.

    We also have two additional interim analysis scheduled through the year at 25% enrollments which should occur during the summer and as 50% enrollment which is anticipated for the fall of this year at 25% and it will be a statistical safety announcement. And at 50%, there will be a statistical safety and efficacy analysis which will include the elimination of utility.

    I will remind you that this is a very powerful utility analysis in that drug must be trending positively against the comparator and order for us to eliminate utility.

    REGULATE-PCI was accepted to complete enrollments in the fall of 2015, and for us to have top-line data by the end of 2015. We’re very excited about the upcoming year and the milestones that we intend to hit. And the company continues to execute exactly accordingly to plan."

    crimsonbey ~ this is SA's transcription and I think you can see where it comes up a bit short, but the info you asked about is there.

    Thanks for the contribution and always be well...

    Michael Webb
    Apr 20 05:08 AM | 2 Likes Like |Link to Comment
  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC [View article]
    dcxavier ~

    I had a contributor email with the same info on Cubist. My reference to the adcom included Cubist because it was Entereg's cardiovascular issues at the time, in conjunction with Relistor's, way back in 2012 that got the ball rolling on this adcom.

    I'm happy that Cubist has a superior product in late stage testing. They were smart to power their study to the max, which it appears that they've done. And, I'll agree that this further complicates NKTR/AZ's plight in June, though I remain convinced that they get approved in September w/out any CVOT requirements.

    I also, agree with most all of your comments, especially those pertaining to Salix/PGNX.

    Please remember that though I loosely follow all biotechs, I'll never claim to be up-to-date on each one that I reference.

    Michael Webb
    Apr 20 05:04 AM | Likes Like |Link to Comment
  • Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC [View article]
    Please tell your associate how much that means to me - 0. I always remind myself of the number of times someone has been responsible for my investment choices - 0. It is nice however to be treated kindly as both growth geeks have treated me.

    Thank you, do your own due diligence and always be well.

    Michael
    Apr 20 04:56 AM | 1 Like Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    Thank you MagicQuote2014! Pertinent info and supportive of position regarding the company's future fortunes.

    I believe the market reflects investor sentiment. The realities of becoming a commercial stage company are extremely different from a developmental past. Even if approved without caveat, MannKind will go through the lull between approval and launch, and then the many months of daily anguish as investors cry out for numbers that will begrudgingly be offered by those with paid access to those sales providers.

    MW
    Apr 18 02:45 AM | 1 Like Like |Link to Comment
  • Expect Biotech Rally To Lead To Further Selling Of Research Stage Companies [View article]
    You're wrong! The biotechnology sector is heartier than you realize. It's because value is assessed based upon the intangible assets of intellectual property, managerial expertise, therapeutic space potential, investor emotion, and the psychological aspects of each of these elements weighing on each other, that make biotech the only market sector where a truly savvy investor can become rich.

    Biotech will rebound with a vengeance and the rising tide will lift all boats.

    Michael Webb
    Apr 17 06:33 PM | 5 Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    Once the door is opened to Afrezza, and the dreamboat inhaler becomes commonplace in the patchwork of our healthcare system, I believe you'll be spot on in assessing its impact. More applications for its use will sprout up and it could in fact become as valuable, or even more so, than Afrezza itself.

    My article is once again, a cautionary piece that after 9 successive endorsements was badly needed.

    Look for writers to jump on this topic following approval as a means to enhance value in the company. It's there!

    Having affirmed your enthusiasm, I can only say: 'let's get there first.'

    Michael Webb
    Apr 17 03:51 AM | Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    MD Research ~

    What a comment! What a man! Thank you.

    Michael Webb
    Apr 15 03:36 AM | Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    Jeb, if I knew how to, I would. I would have done so with my last Sunshine Heart article and first MannKind article. I never however, would have held any position through adcom, as I believe that is the definition of gambling.

    Michael
    Apr 14 05:54 AM | Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    Rcheck ~

    Actually, I'm glad you asked.

    I'm passionate about the stock market. And that's why I write most of the articles I author. When a subject matter peaks my interest, I express an opinion. Especially when doing so provides a larger perspective of a given investment.

    I've been compensated by Seeking Alpha for this article only. I wrote it, not for the money, but for the joy of providing an alternative view of the present situation.

    None of the articles I've written, this one included, have been against MannKind the company, or Afrezza the product. Rather, they've been cautionary to investors who I believe are often mislead into holding positions in companies that they would be better served to reduce their exposure to.

    At this time, and moving forward, I don't believe that holding MannKind stock, especially for the next several months is in any investors interest. I've stated why.

    I've also allowed for the possibility that I could be wrong. I've even suggested ways that the company could enhance shareholder value by announcing a tentative partnership agreement - which was cautionary to shorts who might be lulled to sleep thinking that MannKind was powerless to shape its own destiny over the coming three months of FDA reveiw.

    Some folks simply enjoy writing Rcheck. Not everyone has an agenda, an axe to grind or profits to make for themselves or others.

    That said, when I figure out how to buy puts effectively, I'll do so when publishing my opinion pieces in the future, because I believe I should be rewarded for the thoughts I convey as they are based on the facts at hand.

    Also, all of you who enjoy critiquing me in anonymity, defaming me in anonymity and otherwise engaging in abusive behavior, know this - I stand by my truth enough to put my name to it. And I will defend it, even if necessary, in a court of law.

    Always be well...

    Michael Webb
    Apr 14 05:48 AM | 1 Like Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    And I just realized, I didn't answer the question completely.

    If Alfred doesn't sell, then I think there will be restrictions placed on entry into the market. That will inhibit their ability to partner in a way that provides for a big stock price increase and therefore, the stock price might not return to near $8 a share for some time.

    And yes, I mean that.
    Apr 13 05:35 AM | Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    smokenmirrors ~

    I love you dude, and I really wish you'd write articles as your analysis is dead on.

    Here's why I mentioned the part about the share price. I've been of a mind for awhile now - the last three years, that Alfred Mann (who I believe is human and amazing) is equally stubborn. And so I hope he understands the political atmosphere he's breathing in.

    As you know, some people just don't get it. For instance, there's this chap Spiro Rombotis, president of Cyclacel Pharmaceuticals who has a compound that likely will be the first approved therapy in AML in over 40 years, not because it's a scientific miracle, but because it's an oral medication well targeted to an elderly population. The problem is, Spiro Rombotis is the most insecure person on the planet. He can't negotiate an agreement without feeling like he's being cheated.

    Furthermore, he resorts to lying when he gets scared and then no one trusts him.

    People have their blind spots. Can Alfred Mann trust the folks at Novo not to bury his inhaler once acquired? Can he see that there's no guarantee of immediate adoption and therefore, not demand the world (meaning $25 - $50bn) in return?

    What's the fair price for MannKind right now. According to some, it's the world. I got bad news for them. It's not gonna happen.

    There are other questions. The inhaler itself, how much does each one cost to produce? These aren't toys. Each one needs to be inspected to make sure it works. One manufacturing flaw and thousands of patients get the wrong dosage. That's a problem.

    Mathew says they'll be free with every prescription, but nothings free.

    These are complex negotiations where each party has to give something to get something. I just hope that Alfred Mann is prepared to give up the one thing I don't think he can - control of Afrezza's destiny.

    If he can't, then politics comes into play. Because we're talking not about sharing a $12bn market but someone coming in and taking it away.

    Thanks for your input. Always intelligent, respectful and uplifting.

    Oh and by the way, to all of you. When someone writes a short piece on one of my stocks, I get mad. I do. But that madness comes out in the form of questions and comments, and sometime a thank you for bringing something to my attention that I may have missed.

    We all have a lot to learn from smokenmirrors and pcaflisch.

    Michael
    Apr 13 05:29 AM | 1 Like Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    B_Banzai ~

    I'll run with your interpretation of the Z adcom and "purveyor of doubt" as I can accept both. The point is and always has been, you're not out of the forest yet. I'm also significantly nonplussed by those who are eager to protect their assets by claiming there's "no doubt" when at the present moment, doubt is the only certainty.

    I'm also a little baffled by those who put Alfred Mann on this lofty pedestal when it was under his guidance that a change in devices was made in the midst of the last pivotal phase 3 trial. That's not at all bright.

    Now, someone here suggested that a dosing change was made midway through this trial, and while that's probably of little significance - think Vanda and the changing of their primary endpoint midway through their tasimelteon trial, it is evidence that unless the FDA approved the change, MannKind management didn't learn their lesson the first time.

    Sure, the FDA probably would have mentioned it by now, but who knows?

    And that's the point.

    Michael
    Apr 13 05:10 AM | Likes Like |Link to Comment
  • The Stalled State Of MannKind [View article]
    Wiseman1 ~

    "...if the author had the diabetes his articles would be completely different it is always sad to see how little compassion there is among some folks and then give them a forum to show it off."

    Now this is the kind of comment that bothers me the most. Not because there's any truth to it, but because there isn't.

    Wiseman1 ~ no one then, in your mind, should write a piece that is in any way lacking in complete support for any product that might benefit diabete's patients, correct?

    So, if I had cancer then, I shouldn't write a piece critical of any stock or company who has a cancer product, yes?

    Do you see how ridiculous that is? Regardless of whether or not each product serves the medical need it was created to address, these are not charities that we're investing in. They're money making enterprises.

    How much salary has the staff at MannKind made over the years on everyday investor's money? I read somewhere recently, that five of them are making nearly $5M a year. That's $25M and that's no charity! Get real!!!!!!

    Where in my article have I criticized Afrezza the product? Where in any of my articles have I done that? I haven't! Why? Because that's not the only factor affecting shareholders chances of approval. There are many others. There always are.

    Sometimes, market saturation is an issue. If you have a cancer drug that's beneficial to cancer patients and therefore should be approved, watch out! If there are six other therapies on the market in that same space, you might not get approved. I've seen it happen. And shareholders all cry conspiracy on the part of the FDA when it does. There isn't any however.

    Sometimes the drug isn't good enough. Sometimes the trial is poorly structured or poorly implemented. But to your naive way of thinking, we should all remain silent in deference to the patients who might benefit from the drug under scrutiny. Nonsense!

    Lastly, please stop demonizing people for taking positions counter to your own. I write about stocks. And my intention is to protect investors from the irrational exuberance of charmed investors who only see these companies through rose colored glasses.

    Shame on most all of you in the comment thread of this article and each of the other three I wrote on MannKind. Nothing in them was an attack on Afrezza, diminishing to the plight of those suffering from diabetes or anything other than an attempt to provoke thought outside the box of normative thinking.

    There are many times when I simply want to walk away from writing here. There's no money in it. And increasingly, there's no satisfaction in trying to be of help - pcaflisch the notable exception.

    My intention is in my sign off to most responses made to comments like yours.

    Always be well...

    Michael Webb
    Apr 12 04:46 PM | 1 Like Like |Link to Comment
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