in4thelonghaul

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  • 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
  • Rexahn Pharmaceutical Shares Are Still A Buy Despite Recent Volatility  [View article]
    The recent capital raise at $1.05 (plus warrants) seems likely to put a floor under the s/p at around the $.95 area - but as regards the very early stages and the lengthy timeline involved to bring even the most advanced pipeline candidate to commercial success are likely spot on. One has to wonder if that recent meteoric s/p rise wasn't pretty much connected to and coordinated with Roth.....was it a pump-n-dump(?) - not in the classical nefarious sense, but is it way early to expect only a short consolidation before the 2nd stage ignition sends the s/p past $2...yeah, I would think so. OTOH when a developmental biotech hooks up with an aggressive 'patron', even at such early stage (pre-P2 results), then one can never be sure; in other words, I wouldn't be too quick to label this the proverbial dead-money.
    Jan 20, 2014. 12:03 PM | Likes Like |Link to Comment
  • MannKind Corporation: One Large Step For Shareholders, One Gigantic Step For Diabetics  [View article]
    And that, the well known//well deserved reputation for corruption within FDA, unfortunately is the real fear for all who wish to see Afrezza available to the US diabetic population. Whose ox stands to be most severely gored, and the political influence, direct or indirect, which they have with FDA. I am doubting they will outright refuse approval, but I can see them cluttering up the label sufficiently to greatly hinder Afrezza's market penetration - and sadly, I think they would do this intentionally. Luckily, there is always the EMEA and rest of world as well.
    Jan 8, 2014. 05:00 PM | 2 Likes Like |Link to Comment
  • MannKind Corporation: One Large Step For Shareholders, One Gigantic Step For Diabetics  [View article]
    C S Strum - pure BS

    What an absurd ridiculous comment.....the average insulin dependent diabetic requires from 3 to 5 prandial injections and 1 or 2 basal injections per day.

    Only roughly 5% of the diabetic population fall into the Type-1 category.

    Nice try Shorty - you better cover soon, as Afrezza is both superior in efficacy and safety to any other fast acting insulin on the market; it will quickly capture 20% of any market where it is available, eventually capturing over 40% of the market.
    Jan 6, 2014. 01:18 PM | 9 Likes Like |Link to Comment
  • MannKind Corporation: One Large Step For Shareholders, One Gigantic Step For Diabetics  [View article]
    Absolutely dynamite first effort on this MNKD report.....just a bit of advice though - you shouldn't try to cram everything into too few paragraphs, it is okay to write a bit more in depth! LOL : )
    Jan 6, 2014. 12:07 PM | 2 Likes Like |Link to Comment
  • Rubicon Minerals: An Interesting Bullish Case But Major Risk Remain  [View article]
    Excellent point regarding the tax credits.....puts a different spin on the potential attractiveness of RBY as an acquisition.
    Dec 19, 2013. 11:00 AM | Likes Like |Link to Comment
  • The Race To Treat Stage III Melanoma Just Got A Lot More Interesting  [View article]
    Agreed re. Provectus Pharmaceuticals (OTCQB:PVCT) and the apparent phenomenal efficacy of PV-10 in MM; this company, in spite of the recent attention and share price appreciation, still sports a MC of ~ $200M and appears to be flying under the radar of most.

    Latest P2 indications, presented recently at ECCO, have PV-10 achieving a 51% ORR (26% CR & 25% PR) among melanoma patients (stage III - IV) refractory to a median of 6 prior interventions!

    My understanding is that PVCT has been awarded orphan drug status and has just concluded a meeting with FDA Oncology Division...so investors have to wait until specifics are released as regards the path to be designated for eventual approval; some indications the company has sought 'breakthrough therapy designation', or there is the 'accelerated approval' route as well. With such stunning indications of efficacy in a trial population which has proved wholly resistant to numerous other treatment interventions, one could speculate that the FDA might just grant the breakthrough therapy designation outright and forego the need for a larger P3 trial. It should be noted that Pfizer now has 2 senior persons on the PVCT board, and that PVCT leadership has apparently not been shy in expressing their intention to eventually sell the company.

    *Indications that PV-10 may have efficacy with liver and lung cancers as well.
    **There appears to be some rumor that PV-10 has achieved even more impressive indications for efficacy among recipients in their compassionate use program (CUP).

    From a 10/02/2013 'pharmiweb' writeup - "Metastatic Melanoma: blistering in PV-10 treatment predicts good outcome" :

    "The take home message is that if you have injectable tumours and inject them with PV-10 there’s a one in two chance that you will achieve a clinical response, and for these patients an additional one in two chance that a non injected (bystander) lesion will respond,” said Sanjiv Agarwala, the Principal Investigator of the study from St. Luke's Hospital Bethlehem, Pennsylvania."

    http://bit.ly/1c2FG7V
    Dec 18, 2013. 11:25 PM | Likes Like |Link to Comment
  • Rubicon Minerals: An Interesting Bullish Case But Major Risk Remain  [View article]
    Thanks for your input S.E.Wells - you never fail to bring valuable insight to the discussion at hand.
    Dec 18, 2013. 09:46 PM | Likes Like |Link to Comment
  • Brigus Gold Will Need More Cash  [View article]
    Considering those latest drill results....a buyout of BRD seems a no-brainer. Besides AUY, who do you suppose is likely to be most interested in BRD?
    Dec 3, 2013. 05:59 PM | Likes Like |Link to Comment
  • Provectus Pharmaceuticals Up 17% In A Month; Potential Still Huge  [View article]
    Just beginning some DD, but have to admit that a 3-year delay stretches the bounds of credulity here.....I mean considering the apparent efficacy - still, stranger things have happened, especially when dealing with a basically green mngt. team; at least they have the guy from PFE on board. An genuine update with some hard verifiable stats on the CUP results might go a long way to dispel doubt.
    Nov 28, 2013. 09:59 PM | Likes Like |Link to Comment
  • How Do You Fake 7 Of 16 Five-Year Glioblastoma Survivors?  [View article]
    Absolutely outstanding contributions here Red Acre - Bravo.
    Nov 25, 2013. 09:31 AM | 1 Like Like |Link to Comment
  • Orameds's Success In Type 1 Diabetes Could Solve Novo Nordisk's Problems  [View article]
    Just to let you know - in the recent Afrezza trials, it has been indicated that roughly half, or a bit more, of the total hypoglycemic (low blood sugar) events were all reported from just one trial participant!

    One could easily speculate that this individual was NOT following protocol - those with a conspiratorial bent could even conjecture that this individual was intentionally trying to influence the trial results in a negative way - hmmmmm? Just food for thought, and something readers should be aware of.

    BTW, a regular poster on the Yahoo MNKD message boards by the name of 'afrezzauser' has actually participated in the trials, and yes this 'fact' has been verified - he reports stunning results regarding the effectiveness of Afrezza use in controlling his blood glucose levels and eliminating hypoglycemic episodes; I believe he actually has stated that except for the trial protocol, he feels he could have achieved even better results than he achieved during the trial. So apparently, if one throws out the reported hypoglycemic events reported by this one other trial participant, then Afrezza delivered an absolute homerun as regards overall efficacy/safety - the reduction in low blood sugar episodes for everyone else was much more impressive than the trial stats might at first indicate. *I believe, from memory, this information was alluded to in a post-trial interview which Al Mann (CEO of MNKD) participated in - I didn't actually see this interview but have read of it.
    Nov 23, 2013. 10:25 AM | Likes Like |Link to Comment
  • Orameds's Success In Type 1 Diabetes Could Solve Novo Nordisk's Problems  [View article]
    JFTI.....appears my comment critical of Sharon's article has also been deleted. It is odd, it appeared deleted, then it was back and now apparently it is gone again. Suffice it to say that MNKD's Afrezza is a perfectly safe (in fact safer) treatment which is superior to any fast-acting insulin available - enters the bloodstream in 12 to 15 minutes and is eliminated well before other insulins...very very similar to the functioning of a healthy pancreas. It will greatly increase compliance, and all but eliminates the danger of a low blood sugar emergency which, in worst cases, results in death - so Afrezza will literally save lives; the compliance benefit is so obvious that it needs no explanation....but increased compliance results in huge cost savings to society overall, and I do believe 'huge' is an accurate adjective to describe the long-term $ savings which will accrue and benefit the US/Global healthcare system.

    The only reason which Afrezza may continue to be unavailable to US diabetics is the FDA.....anyone informed knows of their track record.

    Just ask yourself whose ox will be gored by Afrezza approval and then you are free to speculate on the money trail and subsequent events. FDA has already delayed Afrezza approval for years....luckily this time around MNKD is seeking approval in Europe and rest-of-world, so if FDA again seeks to delay approval at least US diabetics should eventually be able to get access through round-a-bout means if they choose to go that route; not to mention the FDA will look very very conflicted and may finally open themselves up to long overdue oversight. Oh that we had an FDA free of the political influence of BigPharma's money. One never knows, even the top echelons of FDA may have limits as regards how far they will go - let's all hope so, for the sake of soooo many.

    *Won't be surprised if SA now puts my original comment back up.
    Nov 13, 2013. 10:29 AM | 2 Likes Like |Link to Comment
  • Rexahn's Recent Clinical Data Points To A New And Better Chemotherapy Pill  [View article]
    Oh really? Hmmmm, so the 'disarray' caused them to just abandon a potentially absolute blockbuster new drug which apparently demonstrates significant efficacy in like 50 human cancer lines? Maybe...............but, something tells me there is likely more to this story than simply a shortsighted hair-brained mngt. screw-up due Teva's ongoing refocusing. Stranger things have happened, but it is pretty uncommon and Teva is known as a pretty savy player not given to such oversights.
    Oct 7, 2013. 10:36 AM | 1 Like Like |Link to Comment
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