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VIVUS Inc. Message Board

  • mooky8639 mooky8639 Feb 26, 2013 4:04 PM Flag

    Tim Morris Is At 2 Conferences Tomorrow

    It could be interesting.

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    • Keep him away from the booze.

    • Here is a copy of his notes for the conferences -
      PART I
      This Form 10-K contains "forward-looking" statements that involve risks and uncertainties. These statements may typically be identified by
      the use of forward-looking words or phrases such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan,"
      "potential," "predict," "opportunity" and "should," the negative use of these words or other similar words. All forward looking statements
      included in this document are based on our current expectations, and we assume no obligation to update any such forward looking statements.
      The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward looking statements. In order to comply with the
      terms of the safe harbor, we note that a variety of factors could cause actual results and experiences to differ materially from the anticipated
      results or other expectations expressed in such forward looking statements. The risks and uncertainties that may affect the operations,
      performance, development, and results of our business include but are not limited to: (1) our limited commercial experience with Qsymia™ in
      the United States, or U.S.; (2) the timing of initiation and completion of the clinical studies required as part of the approval of Qsymia by the
      U.S. Food and Drug Administration, or FDA; (3) the response from the FDA to the data that VIVUS will submit relating to post-approval
      clinical studies; (4) the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation
      Strategy, or REMS, requirements; (5) the impact of distribution of Qsymia through a certified home delivery pharmacy network; (6) whether or
      not the FDA approves our amendment to the REMS for Qsymia, which, if approved, would allow dispensing through select certified retail
      pharmacies to increase access while meeting all requirements of the REMS; (7) that we may be required to provide further analysis of
      previously submitted clinical trial data; (8) the negative opinion of the European Medicines Agency's, or EMA, Committee for Medicinal
      Products for Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for Qsymia; (9) our ability to successfully
      commercialize or establish a marketing partnership for avanafil, which will be marketed in the U.S. under the name STENDRA™; (10) the
      ability of our partners to maintain regulatory approvals to manufacture and adequately supply our products to meet demand; (11) our history of
      losses and variable quarterly results; (12) substantial competition; (13) risks related to the failure to protect our intellectual property and
      litigation in which we may become involved; (14) uncertainties of government or third-party payor reimbursement; (15) our reliance on sole
      source suppliers; (16) our limited sales and marketing and manufacturing experience; (17) our reliance on third parties and our collaborative
      partners; (18) our failure to continue to develop innovative investigational drug candidates and drugs; (19) risks related to the failure to obtain
      FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; (20) our ability to
      demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; (21) the timing of initiation and
      completion of clinical trials and submissions to foreign authorities; (22) the results of post-marketing studies are not favorable; (23) compliance
      with post-marketing regulatory standards is not maintained; (24) the volatility and liquidity of the financial markets; (25) our liquidity and
      capital resources; (26) our expected future revenues, operations and expenditures and (27) other factors that are described from time to time in
      our periodic filings with the Securities and Exchange Commission, or the SEC, including those set forth in this filing as "Item 1A. Risk Factors."

    • jcanty8058 Feb 26, 2013 5:45 PM Flag

      he has nothing to say,unless something great happened since last evening.he would.nt know about it tat soon.he is a waiste of the company'smoney.

      Sentiment: Hold

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