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Bavarian Nordic A/S Agrees on Interim Analysis with FDA and Provides Update on PROSPECT Phase 3 Trial


Monday, 8 Apr 2013 01:00am EDT 

Bavarian Nordic A/S announced that the Company plans to conduct an interim analysis of the on-going PROSPECT Phase 3 trial of PROSTVAC in prostate cancer patients with metastatic disease. The updated statistical analysis plan for the trial, which was recently accepted by the Food and Drug Administration (FDA), now includes pre-specified interim analyses of data that will be performed to evaluate whether the trial should continue as planned or potentially be stopped early for efficacy. In such case, a Biologics License Application may be filed at an earlier stage, potentially shortening the overall development time. 

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