Berlex Files Application for the use of Betaseron in patients with a first clinical episode of MSBerlex announced today that the U pharmacy journal .S. Food and Drug Administration approved the submission of a supplemental Biologics License Application accepts Requesting a expanded label for its multiple sclerosis therapy, Betaseron .
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With the exception historical information contained herein this press release constitute forward looking statements that involve risk and uncertainties, human therapeutics. PROVENGE by men suffer prostate cancer, risks of and insecurities to be treated, that the presentation of data to the with FDA and registration on product application the FDA and risks and uncertainties at the process of discovery development and commercialization of drugs that are are safe and effective for use as human therapeutics. Among the factors that can cause such differences part risks related to to our limited operating history, risks could relating to completing our clinical trials, the risk that safety and / or efficacy results of existing clinical studies or from additional clinical trial on PROVENGE will do not supporting authorization for a biologics license, a risk that the FDA is interprets may handle data differently as the we are or need further information or a closer analysis of the dates than anticipated, risk that the FDA may do not hereby approved one product for one biologics license was applied is randomized, a risk that the results of of a clinical trial of PROVENGE or other product areas can be not necessarily indicative of results of in later clinical trials, risk we require the financial resources and access to capital clinical trials and marketing of PROVENGE funds, our dependence lack perhaps obtain the efforts of the third party, and of our dependence on intellectual property. Additional information about the factors and effect affect Dendreon financial condition and results financial and earnings situation of the Group into disclosing Dendreon submissions to the U.S. Securities and Exchange Commission, that contain among themselves.