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Rich Steffens

 
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  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    After the RS, if it happens, a new CUSIP number is issued driving out the naked shorters I think came from the 2008 loan. You have it backwards.
    Oct 13, 2010. 11:25 PM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    They haven't reached the formal interim endpoint mark. That will be 90 Days for all subjects enrolled. The data on hypoglycemia is quicker to access vs A1C, since the A1C involves a three month timeframe. I see you once thought this data meant something on its own:

    "Severe hypoglycemia is the primary safety concern in insulin therapy. I'm looking at this, which shows 37% fewer incidents of severe hypoglycemia. How is it that you have decided this offers no benefit?"

    seekingalpha.com/user/...

    Without a doubt, the primary endpoint is non-inferiority comparing the A1C levels of the treatment and control group. But the safety data, which is remarkably positive to date, offers a clear benefit. I think they need to stay listed for multiple reasons.
    Oct 12, 2010. 10:05 PM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Capital wasn't even available at that time for the someof the best of companies. A large amount of similar R and D biotechs went belly up. At least, Generex is still here and is positioning themselves for a successful future. Tapping into the direct to consumer market is a smart move on many levels. Even GMD today is growing at a nice clip. In a few qrtrs, I think the balance sheet will look much more attractive, and open up more solid ways to raise capital that benefits shareholders like all of us. I like the synergy and think the risk reward of the deal is favorable. Nothing is certain, but I did like what they talked about in today's CC.
    Oct 12, 2010. 07:30 PM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Generex has a low qrtly burn rate and very little debt. Their most recent 4 or 5 financings were not toxic, as we did see in 2008. That is what I keep repeating, that the toxic financing seen for a microcap biotech during the fianancial meltdown is a mirror image of what is seen on the bulletin board today. A R and D company will always need access to capital by issuing shares, and I don't welcome that happening while on the bulletin board. We may not all agree, but my main interest is in protecting the value of my holdings. I forsee worse dilution on the bulletin board, than after a rs. And in the article, I carefully tried to explain why.
    Oct 12, 2010. 07:22 PM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    No, I didn't overlook the treasury. I mentioned the Nasdaq 20% Rule, and how that level of dilution would most likely only be able to occur on the bulletin board.
    Oct 12, 2010. 07:14 PM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    The correct answer is... #1. This was a hard argument to convey, and we always have concerns. Generex has never paid or offered me anything, and I speak from my heart and mind.
    Oct 12, 2010. 07:12 PM | 1 Like Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Hi ALME. Exubera was doomed for many reasons. I wtote about them all at the time. Pfizer had a poor educuational and marketing plan. GMD can help provide this not only to diabnetics, but the thousands of doctors on their roster. Their expertise in handling and communicating with insurance reimbursement, and Medicare and Medicaid are one of the reasons I think this is a good deal for Generex. Generex also wouldn't be a desperate biotech as they enter more widescale partnership talks. This reminds me of Libery Medical. Generex presents to shareholder's what looks to be a turn key solution to aid Oral-lyn, as well as the other metabolic products.
    Oct 12, 2010. 07:02 AM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Hi Grecale. Nasdaq has the 20% Rule, so we now how many can NOT be released. At least, if they stay listed. the 750 full allotment of authorized shares goes to the BB. I vote no to that idea!
    Oct 12, 2010. 06:56 AM | Likes Like |Link to Comment
  • Generex 's Acquisition Into the Direct to Consumer Diabetes Market Provides Synergistic Value [View article]
    Hi Gregory. Intelligent post. I have closely followed the warrants tally related to the 2008 loan. The problem was that these warrants were heavily discounted and many had cashless options. I have talked to Generex's financial concultants, hired to get them out of the toxic offerings, who talked to me about how they cleaned out many of the toxic warrants and began to push out the investor's tied to them. The subsequent direct offerings were cleaner, with the normal type of warrants we expect. The bulletin board is a return to the financing Generex was forced to enter when the capital institutions tightened up and Wall Street turned upside down. This is an important time for Generex, and I don't want them to stall. This is not a reverse split in an empty vaccum, but one tied to a smart deal to help support products and anticipated commercial launched for Oral-lyn and Metformin Gum.
    Oct 12, 2010. 06:55 AM | Likes Like |Link to Comment
  • News Next Week for Generex May Reduce Need for Reverse Split [View article]
    Hi Thomas. You found the abstract I wrote about last month. The results are intriguing to me and appear to show buccal insulin being more naturally accepted by the body as opposed to other forms. I wrote that the study is under embargo, as all EASD abstracts are, and the detailed information is not supposed to be revealed until the actual presentation time. I hope the update is accepted positively, not just by traders, but by physicians and diabetics that are learning about the Treatment IND. Anyway, I'm looking forward to chatting with you next week. :-)
    Sep 16, 2010. 04:14 PM | 3 Likes Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    This event starts in four days. The meeting to consider a reverse split, scheduled for tomorrow, appears destined to be adjourned until late October. Nasdaq appears to be enabling the extensions due to positive interaction with the company. Much of the speculation centers around the wording Generex used in a previous 8K regarding their continued listing on the Capital Market. A term sheet agreement was mentioned as something Nasdaq required and that is odd. That must be a result of company provided rational for an extension, ie they are in the process of negotiating a business development opportunity. That is my best guess. Lost in all this is Oral-lyn. Treatment IND sites have been added regularly, and early Phase III trends have been positive. This pending update may serve as a great opportunity to further differentiate Oral-lyn buccal insulin from Mannkind's inhalable Afrezza.
    Sep 16, 2010. 03:41 PM | Likes Like |Link to Comment
  • Analyzing Generex and Throwing Darts With Pfizer's Craig Eagle [View article]
    Hi Thomas, the antibody data for Oral-lyn is encouraging. There may be debate on the clinical significance, but it looks to me like the body is trying to warn researchers about Afrezza.

    I'm voting with you Roxie!

    It is good to see you sstrumello. I am a fan of your blog!

    sstrumello.blogspot.com/
    Aug 26, 2010. 07:08 AM | Likes Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    I hope we hear some HbA1c news soon. The 90 day results for all patients should tell us quite a bit. Generex stated in their latest update that "...along with current trends of non-inferiority using recently collected information and extrapolations clearly positions this study favorably". The main endpoint of non-inferiority can only be established with positive HbA1c levels as compared to the injections of regular human insulin. So I take that as a positive tea leaf.

    I'm not sure what to make of all of Mannkind's financial moves. They had a lot of debt to clean up, and the concern would be how this effects dilution. I have met Generex's capital raising consultant, and he spoke about how he worked to clean up Generex's own issues involving cashless warrants. He has helped free them of their prior capital raising vehicles, and was extremely informed about their pipeline. We spoke in detailed terms about Ii-Key hybrid vaccines and Oral-lyn. I liked that he shared in my enthusiasm, and that he obviously took a lot of time learning about the company. I have the thought that the proposals for a reverse stock split are to buy time and that they do not want to implement the split if it is approved. Anything can happen, but I only want to see the stock go up the right way.
    Aug 16, 2010. 10:13 PM | 2 Likes Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    I just saw this via my phone. I was discussing insulin antibody levels that result from all administered insulin. Early data from Generex buccal insulin appears to reverse that trend, and if proven in further studies, it adds to the growing body of evidence which supports Oral-lyn's safety profile. "News for Generex" was not my headline. I'll let them report their news. I was analyzing new information regarding their flagship product.
    Aug 16, 2010. 09:12 AM | 1 Like Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    "Mannkindfan", the orange line is Oral-lyn. The placebo and injectable regular human insulin are just showing baseline values. There is no significant amount of injectable human insulin during that first hour of the graph. That insulin is too slow. Oral-lyn's time profile is not something I make up, nor did I construct the graph (from a peer review). But the comments you need to use to as you express yourself are a bit telling.
    Aug 16, 2010. 08:26 AM | 1 Like Like |Link to Comment
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