A More Accepting FDA For VIVUS? (VVUS)

VIVUS Inc. (NASDAQ: VVUS) has announced that after recent discussions with FDA officials, the company has been asked (allowed) to remove the Qnexa contraindication for women of childbearing potential in its proposed label on the weight loss drug.  The news is good in that it indicates a possible overlooking of the class of patients, but this also allows the FDA to potentially consider sending the drug back into the drawer.  Included with the resubmission of the NDA for Qnexa was a proposed risk evaluation and mitigation strategy. 

VIVUS is revising its proposed risk evaluation and mitigation strategy based on the FDA’s change.  This is among the topics that VIVUS plans to discuss during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee.  In September 2011 , the company announced that it reached agreement with the FDA on a plan that allowed for an early resubmission of the Qnexa NDA which was made in October and the FDA accepted the NDA for review on November 3 , 2011.  

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on February 22 , 2012.  The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

There is still a lot of time left before the open but shares are so far indicated up around 18% at the $12.00 mark after closing at $10.16.  The prior 52-week trading range is $6.00 to $11.48.

 JON C. OGG

Contact [email protected] for any questions or corrections.