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Biodel Reports Fourth Quarter and Fiscal Year 2010 Financial Results
Date:12/9/2010

pid-acting insulin or insulin analog by the FDA; our ability to secure FDA approval for Linjeta™ and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, and the degree to which we are able to clarify with the FDA related regulatory requirements; our ability to conduct the additional pivotal clinical trials the FDA requested in the complete response letter or other tests or analyses required by the FDA to secure approval to commercialize Linjeta™; our ability to develop and commercialize formulations of Linjeta™ or other rapid-acting insulin or insulin analog formulations that may be associated with less injection site discomfort than the formulation that is the subject of the complete response letter we received from the FDA; the progress, timing or success of our product candidates, particularly Linjeta™, and that of our research, development and clinical programs, including any resulting data analyses; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to enforce our patent for Linjeta™ and our ability to secure additional patents for Linjeta™ and for our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others and the degree of clinical utility of our products; the ability of our major suppliers, including suppliers of insulin, to produce our product or products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report o
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