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User 8204

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  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Dear Maui Guy,

    There are 2 possibilities:

    1) the author is long GNBT and is demonstrating the case for his investment

    2) he has some bizarre and elaborate arrangement with Generex where they pay him to write articles on Seeking Alpha.

    Whilst 2) could be true, as a rational human being I find the simplicity of 1) a more parsimonious explanation of what is going on.

    I suggest you try and engage with Mr Steffens's arguments and ideas rather than throw childish accusations around. That's how reasoned debate works.
    Oct 12 09:19 AM | 2 Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Dear Mr. Kaplan,

    Your post demonstrates absolutely no grasp of the facts.

    1) 750m is the number of authorized shares. They are not "hidden". Every listed company in the world has a level of authorized shares greater than their shares outstanding. It's right there in everyone's financial statements.

    2) Generex cannot issue more than 20% of its share capital without shareholder approval. The risks of dilution are hugely overstated: (a) management has no incentive to issue stock for no reason - they issue shares as needed to fund expansions and acquisitions; (b) even if they could issue the remaining 480m share in one go (which they can't), at today's share price it would equal $215m of new money, which is about twice their current market cap. This is a preposterous amount of money for a small money like Generex to raise.

    3) In reality, Generex needs more working capital (US$25-30m) to see it through to Phase III approval, which should come in 1H 2011. If successful (for which the Treatment IND is a strong but by no means foolproof indicator), their share price will pop substantially, meaning subsequent share issues to raise capital to fund the commercialization of Oral-Lyn will be done at much higher prices, entailing much lower dilution. If Phase III fails, so does the company. Simple.

    You are clearly deranged.
    Oct 12 09:14 AM | 1 Like Like |Link to Comment
  • A Positive Move for Generex Biotechnology [View instapost]
    I agree. Very sensible commentary.
    Sep 30 12:25 PM | Likes Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    If anyone is really interested in the actual science behind alternative insulin therapy, read this recent review from the Journal of Diabetes and Technology, entitled "Oral Insulin and Buccal Insulin: A Critical Reappraisal":

    Far from a ringing endorsement of Oral-Lyn, but it acknowledges it works and if any alternative insulin therapies succeed, Oral-Lyn is the more likely candidate than the alternatives.
    Aug 17 08:12 AM | 1 Like Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    Just found an objective and scientifically independent review of oral insulin in the Journal of Diabetes Science and Technology:

    The authors conclude:

    "In summary, it appears as if therapeutic amounts of insulin can be delivered with oral insulin and buccal insulin; however, large amounts have to be applied in most cases. Whether this low biopotency means a high price once the given development would come to the market is not clear right now, as the costs for insulin per se is not the only factor that determines the price. We should not forget that the better compliance that is probably associated with a noninvasive insulin therapy hopefully enables a better metabolic control and hence reduces the extremely high costs associated with treatment of diabetes-related late complications.

    The pharmacokinetic and pharmacodynamic properties of most developments appear to be appropriate for painless coverage of prandial insulin requirements. Unfortunately, it is not clear if “confounding” factors like meals blunt the metabolic effect in a relevant manner. Also, the reproducibility of the metabolic effect induced is not clear. Without appropriately designed and performed phase II and III trials at hand, it is not possible to make any clear statement about the benefits/risk ratio of the different oral insulin developments. However, if the regulatory authorities accept the data presented by the companies (in some cases, it appears as if the development was not systematic enough), there is a good chance that an oral insulin formulation or the more likely buccal insulin formulation currently in the end phase of its clinical development will be the next alternative routes of insulin administration to come to the market in the United States and Europe."
    Aug 17 07:03 AM | Likes Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    Firstly, there are some revenues but they are low because they have not had approval for any significant sized national markets and currently have very few resources to market aggressively. It takes huge time and effort to get doctors to start prescribing an alternative therapy for a serious disease. That said, lack of revenues concerns me and I would like to see a greater level of disclosure from the company.

    Secondly: please address this very specific question which I have repeatedly asked you. How can Oraly-lyn be a "sham" when the FDA has given it IND approval? Are the FDA mad? Have they not realized the data is rubbish as you allege?

    The FDA have only given out 43 treatment IND approvals ever, and Oral-Lyn is the only one to have been granted for a metabolic disease.

    My suspicion is that you avoid addressing this question because it is a very positive development which doesn't fit in with your view of the company.
    Aug 9 06:16 AM | 1 Like Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    I will assume that your refusal to respond to my questions and counter arguments in a sensible and reasoned fashion is because you are unable to.
    Aug 7 11:21 AM | Likes Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    AF's articles in The Street about Generex are some of the most poorly researched, hysterical and downright disingenuous pieces of journalism I have ever read. They contain no arguments whatsoever, just emotion. In fact, he has had to go back and change them to remove the most egregious lies he printed.

    I don't listen to "pumpers" (or "trashers" like AF). I just look at the facts. I think if the FDA gives you IND treatment approval, your product probably has some merit.

    Answer me this: is the FDA wrong to have OK'd the use of Oral-Lyn in special cases where no satisfactory alternative is available? Are they mad? Have they mis-read the data? Are the people using it under IND going to die?
    Aug 5 11:09 AM | 1 Like Like |Link to Comment
  • Generex: Reverse Split Not Approved [View article]
    Firstly, your comments carry no weight until you explain exactly WHY their data is junk. You make a bold statement and offer no back-up evidence or explanation as to why it is true.

    Secondly, Oral-Lyn is the only metabolic disease product the FDA has approved for its Treatment Investigational New Drug (IND) program. EVER. To get this approval, the product must show sufficient evidence of its safety and efficacy.

    There are 2 mutually exclusive logical conclusions as to what is going on:


    1) What you say in your post is true, and therefore the FDA is acting in a criminally irresponsible manner by letting this total scam of a product, based on "junk data", go anywhere near patients that actually need insulin to stay alive.


    2) It has been demonstrated to the FDA's satisfaction that there is reasonably sufficient evidence that Oral-Lyn is both safe and works and can therefore be used in a small number of special cases to help diabetics manage their disease prior to Phase III being completed. Note, this does not imply that it will get Phase III approval or be a commercial blockbuster, just that on balance, the odds are looking quite good.
    Aug 5 05:41 AM | 1 Like Like |Link to Comment
  • Statistical Power and GNBT [View instapost]
    Great post.

    Fact based. Reasoned. Insightful.

    Exactly what people interested in GNBT need to read, rather than the hysterical manipulative ramblings of Feueurstein and his pals.
    May 11 06:08 AM | Likes Like |Link to Comment
  • Generex's Insulin Product: When a Company Misrepresents 'Compassionate Use' [View article]
    Why is the stock up 7% today? Is it because Adam Feuerstein's articles are incredibly ill-informed and fundamentally horse-s**t?

    Try doing some original research as opposed to piggy-backing on the poorly written blogs of a discredited TSCM journalist with a degree in political science who doesn't know the first thing about biotech.
    Apr 29 12:00 PM | 10 Likes Like |Link to Comment
  • Generex and Its Insulin Spray: Just Hype? [View article]

    Great to hear you'll be enrolling in the IND program. I believe Oral-lyn may prove life-changing for many in your condition.

    Would love to hear bout how you get on with your experience! Maybe you should blog about it so the world gets a real first-hand idea of what its like, as opposed to 5th hand stupid school yard chatter from the likes of clueless bloggers Lowe and Feuerstein.

    Best of luck
    Apr 8 04:26 AM | 3 Likes Like |Link to Comment
  • Generex and Its Insulin Spray: Just Hype? [View article]

    Below I have posted a text from the FDA website explaining what the expanded access IND program means.

    I ask you one very simple question. Is the FDA criminally negligent or has it been satisfied that there is "sufficient clinical evidence of safety and effectiveness to support the treatment use"?


    FDA regulations provide for treatment INDs or other access protocols for patients with serious or immediately life-threatening illnesses who have unmet medical need. See the Expanded Access to Investigational Drugs for Treatment Use Final Rule (Expanded Access Rule) (74 FR 40900, August 13, 2009).
    Under these regulations, a treatment IND, which permits patients access to unapproved drug products under certain circumstances prior to final agency approval, is possible when the following criteria have been met:
    (1) The drug is being investigated in a controlled clinical trial under an IND designed to support a marketing application for the expanded access use, or all clinical trials of the drug have been completed;
    (2) The sponsor is actively pursuing marketing approval of the drug for the expanded access use with due diligence; and
    (3) There is sufficient clinical evidence of safety and effectiveness to support the treatment use (21 CFR 312.320(a)).
    Apr 7 11:45 AM | 8 Likes Like |Link to Comment
  • In Support of Generex from TheStreet [View instapost]
    I agree, the Street article seemed to have a peculiar level of unwarranted negativity against GNBT. Total lack of balance, judgement, research, fact or justification. A piece like that automatically makes one suspicious: what on earth is the author's motivation for such a blindly one-sided and partisan article?

    Poor journalism. Well responded Mr. Stevens.

    There are, however, other concerns with GNBT. Big risk of de-listing from NASDAQ around June unless they start to trade over a dollar.

    Also, management disclosing very little new info on current sales efforts in jurisdictions where Oral-lyn has been approved and very little info on material agreements.

    My take: I love the story, but am v suspicious of management's capability to deliver success.
    Mar 21 07:38 PM | 1 Like Like |Link to Comment