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FDA Extends Lymphoseek PDUFA Three Months and Positive Lymphoseek Meta-analyses Reported


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- First Review Cycle to be Complete by Sep. 10, 2012-

-Lymphoseek Localization Rate 4-5% Better than SC-


Report is Available for Download at: www.lifesciadvisors.com/clients/navidea

Tuesday morning, Navidea Biopharmaceuticals (NYSE Amex: NAVB) announced that the FDA has extended the Lymphoseek PDUFA date by three months. We report that the extension had nothing to do with the safety or efficacy of Lymphoseek as it is standard protocol for the FDA in the situation described below. Also on Tuesday, Navidea announced favorable meta-analysis results comparing Lymphoseek to sulfur colloid, which we describe below.

PDUFA Date Extension is Not Related to Lymphoseek Safety or Efficacy. Importantly, we reiterate that the 90-day extension of the Lymphoseek NDA has nothing to do with the ongoing Phase III study (NEO3-06) of Lymphoseek in head and neck squamous cell carcinoma, or the recent Lymphoseek/sulfur colloid meta-analyses that were presented by the Company. Furthermore, no issues regarding Lymphoseek’s safety or efficacy have been raised to date from the PDUFA extension decision or the ongoing review.  The Company also has not been notified that it will have an advisory committee meeting for Lymphoseek.

In fact, if the agency had been leaning towards rejecting the application, we believe that the original PDUFA date of June 10 would have been maintained and the agency would have issued a complete response letter rejecting the drug outright. Therefore, we believe this is arguably good news as the Agency wants to ensure ample time to review the application and the FDA-requested documents that were recently submitted.

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