NAVB 3/19 5:30PM Navidea Biopharma provides update on European Marketing Authorization Application for Lymphoseek: 'Committee will continue with its review of the MAA' (NAVB) 1.99 -0.04 : Co announced that 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.
Based on feedback received at the meeting, Navidea believes that the CHMP has found the safety and efficacy data submitted in the MAA for breast cancer and melanoma to be acceptable. The CHMP will now focus its review on the remaining areas of product specifications unique to the European application and on data from the Phase 3 study in head and neck cancer. During this process, the MAA remains active but the review clock will continue to be stopped while Navidea works with the CHMP to address these remaining areas.
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