Market Overview

Navidea Announces EMA Continues Marketing Authorization Application Review for Lymphoseek

Navidea Biopharmaceuticals (NYSE: NAVB) announced
today that the European Medicines Agency (EMA) has provided
updated Day 180 feedback and has elected to continue the assessment of
the Marketing Authorization Application (MAA) for Lymphoseek®
(technetium 99m tilmanocept) Injection. The updated Day 180 feedback was
limited to supplemental product specification data and the NEO3-06 Phase
3 study in Head and Neck Cancer, which was submitted later in the MAA
review process at Day 120, leaving less time for evaluation of these new
data. The MAA review clock will continue to be stopped at Day 180 to
await Navidea's responses to the updated EMA feedback. During this time,
the MAA remains active and Navidea will continue its

See full press release

Posted-In: News Guidance FDA Management Global

 

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