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VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
Date:2/28/2011

to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the End of Review meeting, our response to the FDA's complete response letter, or CRL; the feasibility assessment of performing a retrospective observational study of infants born to mothers exposed to 100 mg of topiramate for migraine prophylaxis during pregnancy and the results, if any, from the retrospective observational study, the FDA's interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; the FDA's meeting minutes; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional clinical trials, provide further analysis of clinical trial data or to conduct retrospective observational studies; substantial competition; the impact on future sales under a limited label and restrictions on distribution; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign  regulations; and our dependence on the performance of our collaborative partners.  As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products.  There are no guarantees that our response to the FDA's CRL or their request stemming from the End of Review meeting will be sufficient to satisfy the FDA's safety concerns, and that the FDA will not require us to conduct any additional clinical or non-clinical observational studies, or that any product will receive regulatory approval for a
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