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Navidea Biopharmaceuticals (NAVB) is getting hammered after hours as the FDA rejects the New...
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Monday, September 10, 2012, 5:20 PM ETNavidea 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.
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This news story has 2 comments:
They focused on the trials and missed the "unimportant" details.
Like manufacturing!!