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in4thelonghaul

in4thelonghaul
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  • Provectus: Strong Sell, Ties To Paid Stock Promoters, SEC Halt Risk, Price Target $0 [View article]
    Gee.....I thought Apple began operations out of a residential garage? Silly me!

    Oh, and isn't it odd that PVCT's PV-10 has achieved, at a couple of the most prestigious cancer research/treatment centers in the US, an amazing record of efficacy for advanced recurrent melanoma in patients who have failed multiple other treatments....think the ORR is over 50%! That is better than anything ever approved by FDA - these patients are approaching death's door with no options left, and here comes a treatment which achieves such results and even has a positive systemic effect on distant untreated tumors! Just odd that a 'scam' treatment, by a 'scam' company could achieve such results.....guess Moffitt, St. Lukes, M.D. Anderson are all involved in the scam - yeah, that explains it! ASCO guys must be involved too!! Boy what a 'service' you have provided with this article....your momma must be proud.
    May 22, 2014. 09:22 AM | 3 Likes Like |Link to Comment
  • MannKind: Confidence And Cancer [View article]
    Possibly wrong here, but my understanding is that Afrezza use by trial participants resulted in a very small reduction in lung function, forget if it was like 1% or 3%, but it was quite small....also it was my understanding that upon cessation of Afrezza use, the lung function returned to normal - so there was NO Evidence of lung damage whatsoever. Got that? No Lung Damage.

    Now as for long-term use and the potential for some type of lung function reduction or cancer, over and above what transpires with normal aging, that is what the likely periodic monitoring and registry is for. Obviously, regardless of how 'natural' insulin is, it isn't 'natural' to be delivered directly to the lungs.....so any honest person has to allow for some possibility that a 'problem' may arise with long-term use in some people.

    *BTW..From what I have read in the past, daily exposure to the air pollution one encounters in a number of metropolitan areas of California or possibly Texas is equivalent to smoking a number of cigarettes a day (of course it varies by area, whether one exercises a lot during the worst smog, and time of year).

    What one would do well to keep in mind, is that poor control of one's blood glucose (including wild 'swings') i.e., 'compliance' with one's diabetes/insulin treatment regimen can be devastating to one's overall health - that is a guarantee! So one has to weigh, as best as possible, the benefits of likely increased compliance among most users of Afrezza, and the real likelihood of getting insulin treatment started sooner (proven that many delay insulin treatment due to resistance to the idea of starting injections), against the possibility that a problem may arise from long-term use. All studies/trials to date, animal and with people, indicate NO increased cancer risk, and NO permanent lung function reduction.
    May 19, 2014. 09:32 AM | 5 Likes Like |Link to Comment
  • Google Semantic Search Vringo's Next Play? [View article]
    In L.A.Rick's defense....he said '$600 million +'......that statement is sooo obvious that it is of course a bit odd, but technically it covers an acquisition for say somewhere between $2 to $3 billion; of course there will be no buyout before we get finality on the laches ruling.
    May 3, 2014. 08:29 PM | 1 Like Like |Link to Comment
  • MLV Sees A Good Chance Of FDA Approval For MannKind's Afrezza And 60% Upside [View article]
    It is interesting to note that of those who write 'positive' articles regarding MNKD's Afrezza, all appear to have solid credentials such as yourself and George RHO....obviously one would be hard pressed to make such an argument for those who write 'negative' articles. That said, I must take exception with your ridiculously low s/p projection....'5% terminal growth' seems an absurd projection - but I guess that might at least partly explain your $9 s/p target.

    Honestly, when one considers that Afrezza is not subject to the stringent refrigeration requirements of 'normal insulin', is safer by far in that it nearly eliminates to the potential for the dangerous, even fatal, hypoglycemic attack/insulin shock occurrence which those injecting insulin are subject to, has such obvious implications for increased compliance, and has been demonstrated to be superior to any other rapid acting prandial insulin in almost every metric (equivalent in the others)...it seems a 40% market capture may be quite low.

    Your readers should be aware that insulin sales are increasing globally at approx. a 12% rate, with recent US figures approaching 15%. All professionally done surveys which I have run across indicate Afrezza will achieve a minimum 40% market capture when available. It is also of pertinent interest that although the US accounts for somewhere less than 25% of the global diabetic population, by dollar sales volume it accounts for approximately 50%.

    *BTW.... US Insulin Sales: ~ $8.3 B in 2011..up 14.9% from 2010 - Global: $16.7 B..up 12.5% from 2010 - granted that not all of these sales are prandial insulin (pre-meal), but likely about 75% are.

    By simple extrapolation, 2016 US prandial insulin sales are projected to reach $9 billion...a 40% capture rate would equate to a revenue stream in excess of $3.5 billion; this figure doesn't even include 'rest of world' market capture among the global diabetic population.

    Appreciate your article and your views regarding the high likelihood of imminent FDA approval.....but you need to refigure your share price projections using a realistic P/S metric; hint - consider Celgene's P/S metric of ~ 10, or since MNKD has considerable tax loss to carry forward against future sales one might go more for a P/S metric of say 15 such as REGN is sporting. And there is that significant fact of MNKD's already expensed insulin in storage....I think they project it is sufficient to produce the first $10 billion worth of product. And then of course you are aware that once Afrezza is approved, this will validate their underlying 'technosphere' platform....so I wondering why you didn't ascribe any worth to that.

    I think your readers would be well served to read G. Rho's past articles where he places a s/p target closer to $40 than your $9.
    Mar 18, 2014. 01:40 PM | 19 Likes Like |Link to Comment
  • Activision Blizzard Fails To Have Worlds Patents Ruled Completely Invalid; Case Marches On [View article]
    It's all in one's relative perspective isn't it? Granted, there is still enough potential in the WDDD case, stemming from the relatively low MC as has been argued, to make WDDD a decent investment given a few years and a string of legal victories, but to argue that 'losing' damages from ~ 15-plus years of past infringement....to be left with only ~ 3 years 'worth' seems particularly ludicrous; sure, I guess compared to having the patents totally invalidated because of some clerical error, but this ruling tremendously reduces the potential for profit from holding this investment. My guess is that WDDD will now be subject to the infuriating and withering 'dead-money' shorting tactics which some entity (I wonder who) has been employing so successfully against VRNG. ATVI would have to have rocks for brains to settle now for anything except pennies on the dollar vs what they were facing before the judge invalidated such a huge chunk of past damages. Oh well....luckily I was out of WDDD when this all hit, and was able to enter at 10 cents. As is so frequently the case, it is really the United States' IN-justice system which should be indicted.
    Mar 14, 2014. 07:57 PM | 2 Likes Like |Link to Comment
  • How Will Subconscious Issues Influence FDA AdCom Voting On Afrezza? [View article]
    Michael.....you should really quit with the 'betrayal thing' - it is laughable and completely unjustifiable. Have you ever heard of the journalistic phrase - 'this is off the record'?? You think there might be a reason for such precautions? You seem quite enamored of the martyrs' mantle, viewing yourself as quite the victim and supremely annoyed, or is it embarrassed, that Mr. Rho revealed that you use tarot cards in making your investing decisions and recommendations. If it was such a secret, why did you reveal it. George Rho did everyone a great service by revealing that fact, a fact which you should have revealed upfront to your readers btw. If you want things kept secret, then you reveal them to only your lawyer and your priest....pretty much everyone else has, to varying degrees, a duty to the truth first and the public at large, especially journalists who write with the intent of influencing the decisions of others.
    Mar 7, 2014. 05:41 AM | 2 Likes Like |Link to Comment
  • How Will Subconscious Issues Influence FDA AdCom Voting On Afrezza? [View article]
    pranamyay -

    That my friend is just the point and beauty of Afrezza - it greatly reduces the need for such insulin dose micro-management which is required for optimum results from insulin injections!

    In all of my DD research (quite extensive btw) I have run across a number of those who have actually used Afrezza in the trial setting, or rather I have read of their experiences and impressions, and they have all been extremely positive; they have all reported superior blood glucose control using Afrezza...not to mention the tremendous convenience advantages.

    You may indeed be a pharmacist - if so you should be expected to report even a bit more accurately about Pfizer's 'failed' inhalation insulin 'Exubera', instead of implying that such failure was the result of it not working and then trying to extrapolate a likely failure for MNKD's Afrezza. Exubera, with its huge bong like delivery device, was a "commercial" failure because the delivery device was 10 times larger than MNKD's whistle size device and as such only a small percentage of insulin dependent diabetics were willing to make the switch. BTW, my research leads me to believe that MNKD's technosphere-insulin product 'Afrezza' is not only magnitudes more convenient than Exubera, but technically it is just a significant improvement over Pfizer's....it simply, for a number of technical/chemical reasons, works much better and leaves almost no residue in the lungs. For those who wish to persue this you can start by researching the difference in 'monomer' chemical structure to 'hexamer' chemical structure as it relates insulin and the diffusibility of the two into the blood stream....Afrezza is of the monomer structure vs Eubera's hexamer structure.

    You also make the interesting statement that 'Pfizer already failed, why even try'.....are you serious? Gee, I guess once something has been tried and it hasn't worked....well I guess by your reasoning that one should just quit! Quite lucky aren't we that the early pioneers of flight such as the Wright Brothers didn't ascribe to your philosophy. Of course you are welcome to your opinion.....but my research indicates your opinion isn't based on any serious due diligence whatsoever.
    Mar 7, 2014. 05:19 AM | 4 Likes Like |Link to Comment
  • How Will Subconscious Issues Influence FDA AdCom Voting On Afrezza? [View article]
    Excellent comment yazzbro -

    Another superb example of FDA sabotaging a developmental biotech's AdCom meeting was Arena's first one a few years back. They stacked the AdCom with unqualified participants, some of which admitted that they couldn't even interpret the data and wondered why they were picked for the panel. The FDA also of course not only chooses the questions to be answered by the AdCom participants, but also it is an FDA employee who chairs the meeting....and who can be extremely biased if they choose. Since the unexpected AdCom requirement surfaced, the shorts have been unusually bold in increasing their bets. It is such a total shame that even though Afrezza has been demonstrated, on approximately 6,000 trial participants over a number of years, to be both safer and superior in a number of metrics than anything on the market, that our greatest fear is that of a captured FDA who may willingly put the financial interests of one or two Big Pharma outfits above those of tens millions of diabetics.

    Personally I see little to no need for an AdCom at all; Afrezza has never missed an endpoint and it will, through superior glucose control, near elimination of the dreaded insulin induced hypoglycemic shock or low blood sugar attack, and increased compliance, actually save lives - IF the FDA does the obvious and right thing. The FDA's reputation is so tarnished by so many instances....we can only hope that the current FDA Commissioner is aware and determined not to allow past abuses to be repeated at MNKD's upcoming AdCom. Lives will be literally saved by Afrezza approval...and inversely, lives will be lost needlessly if it is again kept from the US insulin dependent diabetic population. BTW, there is considerable speculation among numerous highly qualified experts in diabetic care that early use of Afrezza among the huge 'pre-diabetic' population might actually keep them from ever progressing into full blown T2 diabetes.
    Mar 6, 2014. 05:58 PM | 2 Likes Like |Link to Comment
  • Argos Therapeutics: Cancer Immunotherapy Using A Nobel Prize Winning Discovery [View article]
    It seems Needham just initiated ARGS at a 'Buy' with a $17 target; Stifel with a $17 target; Piper Jaffray with an $18 target; and JMP with a $17 target. It seems most are expecting positive trial results for AGS-003, which is in the pivotal study for metastatic renal cell carcinoma (mRCC); but then 1H2016 is a long ways off. It seems to me they are likely going to be seeking, or are already shopping for, more capital. Obviously DNDN has had a very tough time turning a profit with their technology.....I wonder how the ARGS model, assuming P3 success and FDA thumbs up in 2017, differs. Too early for me to invest in this here. NWBO looks to be along quite a bit further with their technology and P3 trial, but of course their's is not for mRCC....though the technologies appear similar.
    Mar 4, 2014. 09:32 AM | 2 Likes Like |Link to Comment
  • Thank You For Riding The MannKind Catalyst Train - Please Exit Safely At The Next Available Station [View article]
    G.Rho.....thanks for shedding a bit of light on the author's 'methods', as per his prior admission to you. - LOL

    Not that anyone would be the least bit influenced by this 'article'.

    For newbies possibly unfamiliar with Afrezza's commercial potential (assuming approval of course), I have included one recent message board post.

    "US Insulin Sales: ~ $8.3 B in 2011..up 14.9% from 2010 - Global: $16.7 B..up 12.5% from 2010" by richlittle

    "Using these figures one can extrapolate, using a more conservative say 10% annual increase, that US insulin sales in 2014 should reach ~ $11.5 B....now that may be low and of course not all of that is prandial insulin sales. 2015 figures should be about $12.6 B-plus, again this will be low if the yearly increase is closer to the 15% jump reported from 2010 to 2011.

    Just thought I would throw these figures out there for others. Seems that 2015 US 'prandial' insulin sales might likely be around $9.5 B.....so a 20% capture should be around the $2 B figure just for the US come sometime in 2015.

    Feel free to apply a P/S ratio to that figure....say 10 X like CELG, 12 X like Jazz, or even 16 X like REGN.
    *Just ballpark figures....guessing 75% of insulin sales fall into the prandial market. Apologies if these figures are off by a sig. amount.

    **Using a 10 X P/S metric similar to CELG's....let us assume the US 'prandial' insulin market is $10 billion sometime in 2015 (prandial only..roughly 75% of the total insulin market) - some consider this figure low btw. A 20% capture rate would equate to a $2 billion revenue stream at that point. Now applying our P/S metric of 10 X and you have a MC of $20 billion. Lets say MNKD has 400 million shares, so we divide our $20 B MC by the 400 M shares and we get a share price of $50; if by chance we have 500 M shares, then the s/p with that P/S metric of 10 is $40. Now keep in mind that these figures are for a 20% capture of just the US market. It seems that though 70% plus of the global diabetic population resides outside the US (sorry can't remember the exact figure - it may be over 75%), the US accounts for ~ 50% by $ amount of insulin sales....so we can safely double the s/p for a 20% 'global' prandial insulin market capture. That gives us a s/p of somewhere around $100 if we have 400 M shares, or $80 p/sh if we go with the 500 M shares. You do the math for 2016, 2017, etc. I'm expecting a min. 40% capture rate btw."
    Feb 27, 2014. 02:28 PM | 7 Likes Like |Link to Comment
  • The Future Of MannKind: Reach For The Technosphere [View instapost]
    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.
    Feb 24, 2014. 11:22 PM | 2 Likes Like |Link to Comment
  • Vringo's Shareholder Update And What Investors Need To Know About Patent Reform And This Patent Hero [View article]
    Absolutely love your integrity Justin....your track record speaks for itself.
    Feb 20, 2014. 11:24 AM | 1 Like Like |Link to Comment
  • David Slays Goliath: Vringo Awarded Billion-Dollar Victory Over Google [View article]
    Appreciate your precision KP.....
    Jan 29, 2014. 08:58 AM | 1 Like Like |Link to Comment
  • MannKind Catalysts: Insights About Diabetes Care Metrics And Long-Term Complications [View article]
    "And please note--5.7% of the patient discontinued the drug because of coughs. Don't you think that attending physicians will have an issue with this problem--they sure did with Exubera."

    Oh puleeeze - and you don't think that 6% of any given patient population will discontinue a certain treatment for a variety of reasons....that "5.7%" figure actually argues in favor of Afrezza's likely commercial success! You don't think, were Afrezza the current standard of care, and there was a trial of injectable insulin, that 6% would quit the trial due to the pain and inconvenience of the injections!! Think about the absurdity of your argument. It turns out that the 'cough' which you site goes away after the first week or so....had these trial participants hung in there just a bit longer it is likely their coughs would have vanished as well. Let's suppose, for arguments sake, that 6% of potential Afrezza users just can't shake the cough.....so what? Nobody ever said that Afrezza would capture 100% of the market. Do you realize that Afrezza will be a blockbuster if it captures 5% of the market? By my figures/extrapolation sometime in 2017 global prandial insulin sales are projected to be in the vicinity of $23.5 billion - just a 25% capture equates to roughly $6 billion in revenue....for comparison consider CELG with a current similar share count to MNKD and a current annual revenue of approx. $6 billion. Slap on CELG's P/S metric of ~ 11.....you get a s/p of ~ $170. Split it in two so as to account for a partner if you like....still indicates a s/p in the vicinity of $80. Now if Afrezza were to capture 40% by then, which I consider is easily achievable, and you then have a potential annual revenue stream of $9 billion by 2017/2018; keep in mind that insulin use has been increasing globally about 12% each year. Also keep in mind that a number of the world's diabetes experts are thinking that much earlier use of insulin might keep the huge population of pre-diabetics from ever progressing into full blown diabetes.
    Jan 23, 2014. 12:46 AM | 9 Likes Like |Link to Comment
  • MannKind Catalysts: Insights About Diabetes Care Metrics And Long-Term Complications [View article]
    Your apparent implication that Exubera and Afrezza are so similar as to almost certainly receive the same degree of acceptance among physicians and potential recipients couldn't be further from accurate....Exubera simply was a commercial flop which by chemical/physical design is inferior to Afrezza in efficacy, convenience, and safety (the diminished lung function/residue from Exubera use vs. Afrezza). As regards your apparent adamant belief that physicians will be overwhelmingly resistant to prescribing Afrezza....numerous large professionally conducted surveys, one involving over 600 physician responses, indicates just the opposite of what you contend; to save you the trouble indications are that over 80% (from memory) of physician respondents expect to prescribe Afrezza to their insulin dependent diabetics (except where contraindicated by label restrictions of course). You fail totally to back up your contentions with facts, simply because the facts argue against your position.

    Seems bizarre to honestly doubt that 2 out of ten insulin dependent diabetics will almost immediately upon Afrezza availability (give that percentage maybe 2 to 3 months) be contacting their physicians for a prescription....from there, as word of mouth and advertising kicks in, I expect Afrezza to easily capture at least 40% of the prandial insulin market; granted, to reach 60% market capture will likely take a few years. Imagine no more pre-meal injections, no refrigeration, superior efficacy, and sig. increased safety.
    Jan 22, 2014. 10:29 PM | 11 Likes Like |Link to Comment
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