Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Lymphoseek ® (technetium Tc 99m tilmanocept) Injection. In the CRL, 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 Lymphoseek NDA.
Lymphoseek is a novel agent that has been studied in lymphatic mapping procedures performed to help stage breast cancer and melanoma. Lymphoseek is a receptor-targeted radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
“Receiving a Complete Response Letter is clearly disappointing. However, we remain steadfast in our belief that Lymphoseek holds significant promise in improving the lives of patients who undergo lymphatic mapping procedures to stage solid tumor cancers, such as breast cancer and melanoma,” said Mark Pykett, V.M.D, Ph.D., President and CEO of Navidea Biopharmaceuticals. “We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review. We remain confident that our clinical data clearly demonstrate the value of Lymphoseek in accurately identifying lymph nodes that most likely harbor cancer while producing no clinically significant adverse effects,” Pykett added.
Navidea Biopharmaceuticals will provide additional information during a conference call scheduled for 4:45 p.m. EST, September 10, 2012. The conference call can be accessed as follows:
|CONFERENCE CALL INFORMATION|
|TO PARTICIPATE LIVE:||TO LISTEN TO A REPLAY:|
|Date: Time: Toll-free (U.S.) Dial in # : International Dial in # :||Sept 10, 2012 4:45 PM ET (877) 407-9205 (201) 689-8054||Available until: Toll-free (U.S.) Dial in # : International Dial in # : Replay passcode: Account # Conference ID #:||Sept 25, 2012 (877) 660-6853 (201) 612-7415 286 400036|
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