The factors which cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and / or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA data data differently than we do or require more data or a more detailed analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, to do the risk that the results of of a clinical trial for PROVENGE or other product areas may not be indicative of results in later clinical trials, risks that we need the financial resources and access to capital clinical trials or commercialization of PROVENGE funds, our dependence on missing maybe obtain the efforts of third parties, and our dependence on intellectual property..
The process is carried out by Dendreon to explore the effect of the antigen concentration to CD54 upregulation, a measure of product potency and the immune response. The overall survival data will also be collected. Riteria are essentially the same as the criteria used for the Phase 3 to study enrollment in October 2007 and was completed after receipt of positive data as a primary study Dendreon change the Biologics License Application for PROVENGE. Continue reading