Wednesday, March 19, 2014

European Marketing Authorization Application Update - Navidea Bio

Navidea (NAVB) provided an updated on it's ongoing European Marketing Authorization Application for Lymphoseek a few hours after the market closed today and the stock jumped over 5% in after hours trading.  The company presented oral explanations to the CHMP to address questions regarding the application.  The CHMP stated that it will continue it's review of the application though the company believes that the they are satisfied with the safety and efficiency for the breast cancer and melanoma indications so their review now turns to the head and neck cancer indications.  Unlike the FDA approval which only included use for breast cancer and melanoma, Navidea include the results of the head and neck cancer within the European application which weren't available during the FDA review.  Navidea has a supplemental NDA review target date on Lymphoseek for head and neck cancer on June 16th. 

I've been a long time investor of Navidea and believe that the upcoming catalysts, including EU approval, expanded approval in head and neck cancer by the FDA, and the expanded labeling sNDA at the end of the year, provide tremendous upside for this stock. They also have two phase 3 studies in imaging agents for Alzheimer's and Parkinson's which provide additional long-term catalysts and value. 

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