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in4thelonghaul

in4thelonghaul
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  • 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 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 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 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 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 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 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 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 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 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 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 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 10:36 AM | 1 Like Like |Link to Comment
  • MannKind Stock: High Risk, High Reward [View article]
    Lung function reduction is apparently about 1.5%, and trial results indicate that upon cessation of Afrezza use lung function returns to normal.
    Sep 24 09:10 PM | 1 Like Like |Link to Comment
  • Roth Capital's Dr. Joseph Pantginis Highlights 3 Speculative Biotech Stocks Worth Watching [View article]
    Unfortunately you neglected to mention Northwest Biotherapeutics, Inc. NWBO's DCVax-L which has achieved near equally impressive ~ 36 MOS stats in GBM....also from a small phase I trial as with IMUC's ICT-107; btw, 2 patients from NWBO's phase I/II trial have now surpassed 10-year survival with one actually surviving into year 11.

    Put another way (courtesy of Larry Smith of 'Smith on Stocks')....it seems that from their respective small phase I trials, that roughly 55% of patients treated with DCVax-L and ICT-107 are alive three years after diagnosis versus 16% for standard of care. Also from Larry Smith on NWBO's GBM trial results: "The median survival of the 20 glioblastoma multiforme patients treated with DCVax-L was 3 years (in contrast to only 15 to 18 months median overall survival expected with standard of care). Seven of these patients reached or exceeded 4 years of survival, and five have reached or exceeded 6 years of survival. The expected five year survival for glioblastoma is 3% so that based on historical data only one patient of these twenty might have been expected to survive for five years."
    http://bit.ly/1bab9GQ

    Looks like NWBO raised about $15 M in early August, and is currently recruiting for their 312 patient phase III trial of DCVax-L in the US, the U.K. and Germany.
    Sep 24 04:45 PM | 2 Likes Like |Link to Comment
  • 5 Short Interest Rises To Ponder [View article]
    The upcoming DNDN CFO departure seems to only highlight the increasingly dire financial straits the company is facing.....Deutsche Bank downgrading to 'sell' and Wedbush even actually slapping a price target of 'zero' on them recently merely reflects the growing sentiment among the analyst community that Dendreon simply may not be able to turn the ship around at all, or at least before the need of massive dilution; all things considered, one wonders if DNDN longs may wake up soon to a 40%, even 50% dilution headline.

    Management of these small developmental biotechs can be the difference between success and failure, often regardless the potential of their respective treatments....I doubt many would argue that Dendreon's prior management missteps have all but shipwrecked this once promising pioneer in the still promising field of active immunotherapy.
    Sep 16 12:46 AM | Likes Like |Link to Comment
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