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FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
Date:10/28/2010

www.VIVUS.com">www.VIVUS.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of VIVUS' response to the FDA's complete response letter; the FDA's interpretation of the data VIVUS submits relating to the teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study (OB-305); that we may be required to conduct additional clinical trials; substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that our response to the FDA's complete response letter will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct additional clinical studies or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2009 and periodic reports f
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