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Navidea Biopharmaceuticals, Inc Message Board

nascrazy 4 posts  |  Last Activity: Sep 10, 2014 4:59 PM Member since: Sep 17, 1999
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  • also Wilan positive ruling vs APPLE will tighten the noose for lisencing.

    Sentiment: Strong Buy

  • Other Products of Potential Interest: Lymphoseek
    Dr. Reaman said that Lymphoseek is an imaging agent, not a therapeutic agent. ODAC became
    aware of Lymphoseek during consults because of its intended use in lymphoid mapping in a
    variety of cancers, notably breast cancer, as well as head and neck cancer and melanoma.
    Dr. Donoghue explained that Lymphoseek is a radioactive diagnostic agent indicated for sentinel
    lymph node detection and excision for breast cancer and melanoma and for lymphatic mapping.

    Lymphoseek was recently approved for squamous cell carcinoma of the head and neck. The
    Division of Medical Imaging Products sought an opinion as to whether studies of Lymphoseek
    would be beneficial in pediatric patients. The company (Navidea) was not seeking pediatric
    studies primarily because of the lack of consensus on the role of lymphatic mapping for a variety
    of solid tumors. The patient population may be too small, and there may not be enough
    investigator interest to consider a study. The Office of Hematology and Oncology Products is
    considering inviting Navidea to explore potential pediatric studies at a Pediatric Subcommittee

    Dr. Reaman commented that if Lymphoseek seeks a broader indication it might trigger a
    pediatric evaluation as required by the Pediatric Research Equity Act. There should be broader
    consultation and input before suggesting to Navidea whether pediatric evaluation is warranted.
    Based on the surgical guidelines for pediatric rhabdomyosarcoma and neuroblastoma, a clinical
    trial of Lymphoseek could be considered and a potential pediatric trial could be discussed by the
    Pediatric Subcommittee if there are appropriate experts representing pediatric surgery, solid
    tumor oncology, and imaging. Dr. Reaman asked the working group to provide input on pediatric
    surgeons and medical imaging experts to include in possible discussions of Lymphoseek, if put
    on the agenda for a future ODAC meeting.

    Sentiment: Buy


    Thankful for Diversification, I've gained as much on another stock as this one has fallen.

1.280.00(0.00%)Sep 17 4:00 PMEDT

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