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Navidea Biopharmaceuticals, Inc Message Board

  • moneyonomics moneyonomics Mar 28, 2013 9:09 PM Flag

    4694 Phase IIB will take 36 months for 3 injection process, then final analysis, etc

    again from insideoutsideupsidedown on navb iv board from LifeSci research note

    "...On March 27, 2013, Navidea announced that the first patient in its Phase IIb positron emission tomography (PET) imaging study of NAV4694 for the detection of cerebral β-amyloid plaque in subjects with mild cognitive impairment (MCI).1 This open-label, non-randomized study is designed to investigate safety and to determine whether PET imaging with NAV4694 is able to differentiate between patients with MCI who progress to Alzheimer’s disease and those who do not. Subjects in the study will undergo three injections of the investigational diagnostic NAV4694 over the course of 36 months and will also undergo neuro-cognitive tests during that time. The diagnostic injections and imaging tests will take place at the beginning of the study, after 18 months, and after 36 months. The efficacy assessment will be based on the sensitivity, specificity, and the negative and positive predictive value of the NAV4694 PET scan findings in predicting progression from MCI to Alzheimer’s disease over 36 months. An investigator blinded to the results of NAV4694 PET findings will perform the overall Standard of Truth assessment regarding patients’ cognitive decline and/or progression to dementia....We believe that NAV4694 may have a market potential of $1B or more. If successful, NAV4694 could generate similar interest from potential partners as Avid Radiopharmaceuticals’ Amyvid, which was bought by Eli Lilly in a deal potentially worth $800M...."

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