Navidea Biopharmaceuticals Announces Agreement with FDA on Special Protocol Assessments for NAV5001 Phase 3 Program

Navidea Biopharmaceuticals, Inc.

, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for two special protocol assessments (SPA) for the Company's pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor. NAV5001 is an investigational imaging agent used to visualize dopamine transporters (DAT) in the brain using single photon emission tomography (SPECT) imaging. The SPAs are written agreements between the Company, as the program's sponsor, and FDA regarding the design, endpoints and statistical analysis for the two pivotal Phase 3 clinical trials to be used in support of a potential NAV5001 New Drug Application