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Data From QNEXA Sequel Study Featured at the 47th EASD Annual Meeting
Date:9/16/2011

n the FDA's CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy or FORTRESS; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; 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 the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional  prospective studies or retrospective observational 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 up
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Related medicine technology :

1. VIVUS Provides Regulatory Update on QNEXA
2. Obese Patients Treated With QNEXA Demonstrated Significant Improvement in Quality of Life
3. Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity
4. Multiple Presentations Featuring QNEXA® Data to be Presented at the European Congress on Obesity
5. QNEXA® Phase 3 Data in The Lancet Show Significant Weight Loss and Broad Improvements in Co-Morbidities
6. Weight Loss With QNEXA® Over Two Years Provides Patients With Substantial Cardiovascular Benefits
7. Long-Term Data on QNEXA® to be Presented at The American College of Cardiology Annual Meeting
8. VIVUS Provides Regulatory Update on QNEXA NDA
9. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
10. A Majority of Surveyed PCPs and Endocrinologists Indicate that they will Prescribe Contrave, Lorqess and Qnexa if these Therapies are Approved for Obesity
11. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
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