Replies to post #23 on FDA Approval Treasure Hunters

[sea_devil]

No kidding. Been in that one a long time

[MinnieM]

I'm recycling one of your posts biomanbaba. ;)

Get yourself some VVUS..........FDA advisory committee meeting coming on 7/15/10 re their Qnexa.......my #2 play behind MMRF right now
www.vivus.com/pipeline/qnexa-obesity

Recently, VIVUS, Inc. (VVUS - Snapshot Report) announced that the New Drug Application (NDA) for its obesity candidate, Qnexa, will be reviewed by the Endocrinologic and Metabolic Drugs advisory committee of the U.S. Food and Drug Administration (FDA) tentatively on July 15, 2010.

The US regulatory authority accepted the NDA filed by VIVUS for Qnexa on March 1, 2010. The NDA was filed in December 2009. A response from the FDA should be out in the fourth quarter of 2010 (action date: Oct 28, 2010). Even though the US agency is not bound to follow the advice of its advisory committees, the recommendation of the panel is usually considered by the agency while deciding on the fate of a drug candidate.

Qnexa is VIVUS’ lead pipeline candidate. It is a proprietary oral drug candidate that combines two previously approved products, topiramate and phentermine, to employ a dual mechanism to treat obesity. The drug is designed to address the excess appetite and high threshold for satiety that impact eating behavior. The full dose of Qnexa is a combination of 15mg phentermine and 92mg of a proprietary controlled release (CR) topiramate. Qnexa is being developed to treat other indications also.