Navidea Biopharmaceuticals (NAVB) Provides Update On European Marketing Authorization Application For Lymphoseek®
3/20/2014 10:25:18 AM
DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced that today it held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the pending Marketing Authorization Application (MAA) of Lymphoseek® (technetium Tc 99m tilmanocept) Injection. Lymphoseek is a lymphatic mapping agent designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. As part of the MAA review process, Navidea presented Oral Explanations to the CHMP relating to open questions in the Lymphoseek MAA. At the conclusion of the meeting, the CHMP informed Navidea that the Committee will continue with its review of the MAA. Navidea believes the course of the review continues to be supportive of its market development plans and outlook for material revenue generation in Europe beginning in 2015, as previously disclosed.
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