10:32 ET VVUS
Vivus: In-line AdComm enables focus to return to Qnexa PDUFA - JMP Securities
JMP Securities is confident that the FDA will not require Vivus to conduct a pre-approval cardiovascular outcomes trial for Qnexa based upon their view that: 1) the totality of data for the drug is supportive of cardiovascular benefit and not risk, and 2) the precedent of guidance change for diabetes drugs in 2008. They continue to believe that the risk of a pre-approval outcomes trial requirement is less than 10% and believe the most significant risk to a delay on the April 17 PDUFA is a need for additional time to finalize the risk evaluation mitigation strategies (REMS). They reit. a Market Outperform rating and $45 target.
10:26 ET VVUS
Vivus: Summer Street does not believe that there will be any additional burdens placed on VVUS' Qnexa following panel
Summer Street notes that the FDA's Endocrinologic and Metabolic Drugs Advisory panel favored enrolling patient populations in pivotal clinical trials that are enriched with patients at high risk for cardiovascular disease. The panel favored a two-stage cardiovascular outcome study for all obesity drugs, whether they have shown a cardiovascular risk signal or not. The firm does not believe that there will be any additional burdens placed on VVUS' Qnexa, as the same panel has already recommended VVUS perform a post-approval cardiovascular safety study. They maintain their view that the FDA will approve Qnexa by the PDUFA date (April 17th ) and that Qnexa will be a commercial success.
07:30 Mar-12 07:48 ET VVUS
Vivus: Confusing and poorly run vote, but still think Qnexa goes through - Cowen
Cowen believes the FDA obesity panel's 17-6 vote in favor of conducting a cardiovascular outcomes trial (CVOT) or meta-analysis for compounds without a signal of cardiovascular harm could be interpreted as a negative for VVUS, since if the FDA were to follow the panel's strict recommendation, the company may be required to start a CVOT and wait until at least interim data become available before Qnexa is approved. However, they believe that the FDA will either not apply the panel recommendations to Qnexa since it has already submitted its NDA, or that the FDA will only apply the post-approval CVOT requirement. Therefore, they conclude that it is likely VVUS shares will trade sideways to slightly up leading up to the April 17th PDUFA, and assuming approval, they expect shares to trade to the high-20s. They reit a neutral rating due to residual risk for a CRL and post-approval risk associated with launch and commercialization.
06:56 ET VVUS upgraded to Buy from Hold at Brean Murray
Kurt Vonnegut wrote some great books and had a great philosophy of life:
