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Navidea Biopharmaceuticals (NAVB) is getting hammered after hours as the FDA rejects the New...

Navidea Biopharmaceuticals (NAVB) is getting hammered after hours as the FDA rejects the New Drug Application for its Lymphoseek injection. In the rejection letter, the FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing, and was not related to any efficacy or safety data filed within the drug's application. Shares -37% AH.
Comments (2)
  • rickbrooks01
    , contributor
    Comment (1) | Send Message
     
    Management missed the boat on this!
    They focused on the trials and missed the "unimportant" details.
    Like manufacturing!!
    10 Sep 2012, 11:47 PM Reply Like
  • johnbarleycorn
    , contributor
    Comments (133) | Send Message
     
    Temporary setback!
    13 Sep 2012, 04:30 PM Reply Like
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