vanafil, which will be marketed in the U.S. under the name Stendra, or our partner's ability to obtain and maintain regulatory approval to manufacture and adequately supply avanafil for commercial use; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing and manufacturing experience; our reliance on third parties and our collaborative partners; our failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; the timing of initiation and completion
of clinical trials and submissions to foreign authorities; the volatility and liquidity of the financial markets; our liquidity and capital
resources; and our expected future revenues, operations and expenditures.
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 CHMP's 180-day list of outstanding issues and subsequent meetings and communications will be sufficient to satisfy the CHMP's safety concerns regarding Qsymia, that the foreign authorities will not require us to conduct any additional
prospective studies or retrospective observational studies, or that any product will receive foreign regulatory approval for any indication or
prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors
should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2011, and periodic reports filed with the Securities
and Exchange Commission.
SOURCE VIVUS, Inc.
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