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GNBT - Generex Biotechnology - Deel 2

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  1. svenhedin 2 mei 2008 16:40

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    quote:

    crackedtooth schreef:

    TA bearish, major resistance op 1,20

    Ging de koers eerst maar eens die richting in, dan ben ik al tevreden vandaag.
  2. [verwijderd] 5 mei 2008 18:52

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    Generex Biotechnology (GNBT) quietly released an 8K SEC filing on May 1st. In this "Current Report" they note:
    seekingalpha.com/article/75652-genere...

    Generex Biotechnology Corporation (the "Company") has received Special Access Programme authorization from the Therapeutic Products Directorate of Health Canada for a patient-specific, physician-supervised treatment of Type-1 Diabetes Mellitus with Generex Oral-lyn™, the Company's proprietary oral insulin spray product. Health Canada's Special Access Programme [SAP] provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

    The filing states that a Type 1 patient will be allowed access to Oral-lyn. Her Doctor will record her therapuetic response to Oral-lyn and alert the Director. Investors in Generex hope that positve results may lead to an expansion of the program.

    With this development, Generex Oral-lyn is continuing with its positive momentum at a time the inhalable sector is in decline due the discontinuation of development of inhalable insulin devices by Eli Lilly (LLY) and Novo Nordisk (NVO) and the lung fuction decline and more recent lung cancer concerns raised by Pfizer (PFE) and Nektar's (NKTR) Exubera. These hightened pulmonary safety concerns have brought strong doubt on the efforts of Mannkind (MNKD) in developing it's own inhalable insulin device. Only Generex's Oral-lyn is a fine mist liquid spray where all absobtion takes place in the inner lining of the buccal cavity with no deposition into the lungs.

    What this Special Access Programme [SAP] Authorization from Health Canada illustrates is that current treatment for this Type 1 patient have either failed, were unsuitable, or are unavailable. It is interesting to note that this SAP prgram is allowing the patients Doctor to prescribe Oral-lyn to fill an unspecified and unmet need. This SAP is evidence that current standard insulin injectables, pens or pumps have failed to help this patient. Through this special program, the patients doctor specifically turned to Generex Oral-lyn and Health Canada approved the treatment.

    In one SEC filing, we may find evidence not only of Oral-lyn's superiority vs inhalable insulin, but potentially of it's superiority vs current approved treatment options for a specific Type 1 subgroup. This is encouraging news for Generex and their shareholders, as the microcap biotech continues with recruitment in North America for Oral-lyn's worldwide Phase III trial.

  5. [verwijderd] 7 mei 2008 15:07

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    Generex Study Proposes Increased Reporting of Clinical Outcomes
    to Support Reimbursement of Non-Injectable Insulin Options
    Wednesday May 7,
    8:00
    Findings Presented At International Society for Pharmacoeconomics and Outcomes Research Meeting in Toronto.
    biz.yahoo.com/pz/080507/142133.html

    WORCESTER, Mass., May 7, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has sponsored a poster presentation at this year's International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting being held in Toronto, Canada May 3-7, 2008. The project was carried out by Pivina Consulting Inc. during 2007.

    The title of the poster is ``Non-injectable Insulin -- To Pay or Not to Pay.'' The poster is co-authored by Charles Piwko, N. Mittman, S.J. Seung, Anita Kapoor and George Markus. George Markus, M.Sc., is Generex's Vice President of Regulatory Affairs and Anita Kapoor, Ph.D., is a Regulatory Affairs Associate at the Company.

    The objective of the abstract is to examine what may have contributed to minimal governmental reimbursements of non-injectable insulin costs. The report explores existing insulin treatments and future treatments and the rationales for reimbursement.

    Major findings were that clinical studies for non-injectable insulins did not include adequate information and/or outcomes that are required by decision makers for reimbursement recommendations; patient satisfaction according to the HTA agencies was considered to be an important outcome, but was not well reported in the clinical studies; there is a need to include utility data.

    The report concludes that, since there is a lack of adequately evaluated outcomes demonstrating the link between improved adherence and improved clinical outcomes, there exists a definite need to re-examine the rationales for the lack of reimbursement.

    ``We are pleased to have taken some necessary steps in the assessment of reimbursement evaluations and listing criteria,'' said Rose C. Perri, the Company's Chief Operating Officer. ``This research will pave the way for the conduct of an upcoming utility study of our proprietary oral insulin spray product, Generex Oral-lyn(tm). These Health Economic initiatives will play a role in supporting future reimbursement recommendations.''

    ISPOR promotes the science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical outcomes, economic outcomes, and patient-reported outcomes) and facilitates the translation of this research into useful information for healthcare decision-makers to ensure that society allocates scarce health care resources wisely, fairly and efficiently.

  8. [verwijderd] 12 mei 2008 13:45

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    shortsqueeze.com/?symbol=gnbt&amp...
    quote:

    crackedtooth schreef:

    [quote=SkySpam1]

    Short interest,
    spectaculaire daling van 5.24 naar 3.4??

    finance.aol.com/company/generex-biote...
    [/quote]

    dit is een fijnere link
    beta.nasdaqtrader.com/trader.aspx?id=...

    En deze is nog beter,en meer bij de tijd.(gegevens van mei...die van jullie hierboven van april zie ik)
  9. [verwijderd] 12 mei 2008 13:52

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    jij snapt toch wel dat je onzin kraamt?

    Vaker dan bi weekly worden short data niet geupdate, vroeger was dat 1 maandelijks.

    Dus ja hij geeft mooi de dag van vandaag aan, maar data is nog steeds van laatste nasdaq update, welke dus 30 april was.

    rond 14/15 mei weer nieuwe update.

    tsk tsk tsk
  10. [verwijderd] 27 mei 2008 19:47

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    Generex Establishes Branch Office in Exclusive Dubai Healthcare City.

    Tuesday May 27, 8:00 am ET
    biz.yahoo.com/pz/080527/143479.html

    WORCESTER, Mass., May 27, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has received a Commercial License from the Government of Dubai, United Arab Emirates. Under the auspices of this Commercial License, Generex has established a branch office in exclusive Dubai Healthcare City operating as ``Generex Biotechnology Corporation Mena'' (i.e., Middle East and North Africa). Generex, through this branch office, will work closely with the regulatory and marketing personnel of Leosons General Trading Company, the Company's licensee in the region for the registration, importation, marketing, distribution, and sale of Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product.


    ``This augmented presence in the region will assist Generex to bring Generex Oral-lyn and its new paradigm for the treatment of diabetes to the more than 15 million patients with diabetes in the region,'' said William Abajian, Senior Executive Advisor, Global Strategic Alliances & Business Development for the Company. ``We believe that Generex Oral-lyn(tm), as a safe, simple, fast, and effective alternative to prandial injections of insulin, is poised to become a standard element of the treatment paradigm for the estimated 1.5 million Type-1 patients with diabetes in the region, as well as the estimated 2.7 million Type-2 patients with diabetes in the region for whom insulin is a part of the treatment regime,'' added Mr. Abajian. Generex also believes that, by making its oral insulin product available in place of prandial insulin injections, many more patients with Type-2 diabetes may be willing to include insulin therapy in their treatment paradigms to slow the progression of the disease and the onset of its myriad complications.
  13. [verwijderd] 28 mei 2008 16:49

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    quote:

    ronald76 schreef:

    Zucht,m'n geduld word gruwelijk op de proef gesteld.
    Dat ze maar eens met goede cijfers komen.
    En we wachten....
    Groet,Ronald.
    Ta downtrend al tijdje intact
  15. [verwijderd] 4 juni 2008 17:24

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    ``The completion of the Phase I breast cancer trial for AE37 is a significant milestone and accomplishment for Generex,'' commented Anna Gluskin, President and Chief Executive Officer of Generex.

    Generex Biotechnology Phase I Trial Results for Novel Immunotherapy Vaccine in Breast Cancer Patients Presented At ASCO
    Tuesday June 3, 7:30 am ET
    biz.yahoo.com/pz/080603/143932.html

    Results Conclude Vaccine is Safe and Well-Tolerated in Patients

    To be Published in July Issue of The Journal of Clinical Oncology

    WORCESTER, Mass., June 3, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News) (http://www.generex.com) presented final results of the Phase I trial of the Company's novel AE37 immunotherapeutic vaccine in breast cancer patients at the 44th annual meeting of the American Society of Clinical Oncology (ASCO, www.asco.org) in Chicago, Illinois held May 30 through June 3. AE37, a therapeutic vaccine, is being developed by the Company's wholly owned subsidiary, Antigen Express, Inc. (http://www.antigenexpress.com), for a number of indications in oncology. The Phase I trial concluded the vaccine was safe and well tolerated in breast cancer patients.

    The vaccine is derived from a fragment of the HER-2/neu oncogene, which is over-expressed in a variety of tumors, including breast, ovarian, prostate, colon and lung tumors. The Phase I breast cancer trial was conducted by Dr. George Peoples at the Walter Reed Army Medical Center.

    The completed Phase I trial was a dose escalation study to establish the safety and immunologic activity of AE37 in 15 node-negative breast cancer patients. The patients received 6 immunizations at monthly intervals of 100, 500 or 1000 mcg. AE37 combined with 0 to 250 mcg. GM-CSF as adjuvant. Because of a robust local response in patients receiving 500 mcg. AE37, patients were dosed with 1000 mcg. AE37 in the absence of adjuvant. Even in the absence of adjuvant, two of the three patients receiving 1000 mcg. AE37 required a reduction in the amount of AE37 because of a robust local response, indicating the inherent potency of AE37. Analysis of T cells taken from patients as well as delayed-type hypersensitivity tests demonstrated that there was a significant and specific immune response in patients receiving AE37. A full report, entitled ``Results of the First Phase I Clinical Trial of the Novel Ii-Key Hybrid Preventive HER-2/neu Peptide (AE37) Vaccine,'' has been accepted for publication and will appear in the July issue of the Journal of Clinical Oncology.

    ``The completion of the Phase I breast cancer trial for AE37 is a significant milestone and accomplishment for Generex,'' commented Anna Gluskin, President and Chief Executive Officer of Generex. ``The results of this trial offer proof of our progress in successfully bringing AE37 through the clinical regulatory process. This trial represents the first human experience with the Ii-Key modification, and to our knowledge AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant. We look forward to the progression of our Phase II trial of AE37, currently underway, as well as the possible expansion of our AE37 immunotherapy trials.''

    The AE37 vaccine is based on one of two proprietary platform technologies established at Antigen Express. The technology entails the modification of fragments of antigens to increase their potency in stimulating CD4+ T helper cells, resulting in a more robust specific response to the antigen as well as immunological memory. Currently, AE37 is the subject of a Phase II trial to establish efficacy by preventing recurrence in node-positive and high-risk node-negative breast cancer patients, being conducted by Dr. George Peoples at the Brooke Army Medical Center, and a Phase I trial in prostate cancer patients, being conducted by Dr. Aristides Karagiannis and Dr. Costas Baxevanis at the Euroclinic in Athens, Greece. In addition to the oncology trials, Ii-Key modified peptides derived from the H5N1 avian influenza virus are also the subject of a Phase I investigation.

  17. [verwijderd] 4 juni 2008 21:05

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    quote:

    lucht handelaar schreef:

    Had nu maar naar mijn tip LNG gehandeld,Sky!! van 4,89 maandag naar 6,39 gisteren.
    Hahahahaha,of met mijn FMNT van 0,055 naar 0,11 eergisteren !(plus 100%) en daarna gisteren SPDE(plus 30%) en zeeeer binnenkort ZVUE !(stijging aanstaande!! )
  18. [verwijderd] 4 juni 2008 21:07

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    quote:

    lucht handelaar schreef:

    Had nu maar naar mijn tip LNG gehandeld,Sky!! van 4,89 maandag naar 6,39 gisteren.
    Dat is nog geen 10% man,das niks..100den% daar doe ik het pas voor !
  19. [verwijderd] 4 juni 2008 21:22

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    quote:

    Luchttrader schreef:

    [quote=lucht handelaar]
    Had nu maar naar mijn tip LNG gehandeld,Sky!! van 4,89 maandag naar 6,39 gisteren.
    [/quote]Dat is nog geen 10% man,das niks..100den% daar doe ik het pas voor !
    Zie je wel dat jij de echte luchthandelaar niet bent!! 100den%m laat me niet lachen,man!
  20. [verwijderd] 4 juni 2008 21:26

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    quote:

    lucht handelaar schreef:

    [quote=Luchttrader]
    [quote=lucht handelaar]
    Had nu maar naar mijn tip LNG gehandeld,Sky!! van 4,89 maandag naar 6,39 gisteren.
    [/quote]Dat is nog geen 10% man,das niks..100den% daar doe ik het pas voor !
    [/quote]
    Zie je wel dat jij de echte luchthandelaar niet bent!! 100den%m laat me niet lachen,man!
    Volgens mij ben jij Rac69 !
  21. [verwijderd] 4 juni 2008 21:29

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    quote:

    Luchttrader schreef:

    [quote=lucht handelaar]
    [quote=Luchttrader]
    [quote=lucht handelaar]
    Had nu maar naar mijn tip LNG gehandeld,Sky!! van 4,89 maandag naar 6,39 gisteren.
    [/quote]Dat is nog geen 10% man,das niks..100den% daar doe ik het pas voor !
    [/quote]
    Zie je wel dat jij de echte luchthandelaar niet bent!! 100den%m laat me niet lachen,man!
    [/quote]Volgens mij ben jij Rac69 !
    Volgens mij ben jij Rieltijm.
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