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Advaxis, Inc. Message Board

  • investalot May 15, 2013 6:42 PM Flag

    strong BUY !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

    Business Strategy
    Our strategy is to maintain and fortify a leadership position in the discovery, acquisition and development of Lm-LLO
    immunotherapies that target for cancer and infectious disease. The fundamental goals of our business strategy include the following:
    • Be the first immunotherapy company to commercialize a therapeutic HPV-associated oncology drug. Because we believe
    ADXS-HPV is the most clinically advanced anti-cervical cancer immunotherapy, we aim to fortify our leadership position and
    be the first to commercialize our Lm-LLO immunotherapy for this unmet medical need.
    • Develop and commercialize ADXS-HPV in multiple HPV-associated cancers. We plan to advance ADXS-HPV through
    registrational Phase 3 trials and regulatory approval in the United States and relevant markets for the treatment of cervical
    cancer. If successful, we plan to submit a Biologics License Application, or BLA, to the FDA as the basis for marketing
    approval in the United States of ADXS-HPV for the treatment of cervical cancer. HPV, the target for ADXS-HPV, is
    expressed on a wide variety of cancers including cervical, head and neck, anal, vulva, vaginal, and penile. Accordingly, we
    believe that ADXS-HPV should be active in these HPV-associated cancers and these indications could represent significant
    market opportunities for ADXS-HPV.
    • File three applications requesting Orphan Drug Designation with the FDA and the European Medicines Agency, or
    EMEA, for ADXS-HPV for use in the treatment of cervical cancer, head and neck cancer and anal cancer. Orphan status
    is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases
    affecting fewer than 200,000 individuals in the United States annually, or more than 200,000 individuals in the United States
    and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available
    in the United States for this type of disease or condition will be recovered from sales of the product. Orphan drug designation
    would entitle our company to a seven-year period of marketing exclusivity in the United States for ADXS-HPV if it is
    approved by the FDA for the treatment of cervical, head and neck and or anal cancer, and would

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