Home > Boards > iHub Talk > Other > FDA Approval Treasure Hunters
Followed By 595
Posts 28116
Boards Moderated 3
Alias Born 11/16/2007

Monday, April 05, 2010 2:23:04 AM

Re: biomanbaba post# 23

Post# of 27
I'm recycling one of your posts biomanbaba. ;)
Quote:
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.



Pro Music Rights, Inc., one of the world's largest music licensing companies, announces that it intends to Release its Financials by August 19, 2022 NUVG Aug 11, 2022 11:11 AM

AXTG Partner with Save Planet Earth to digitize and plant 100 million trees with NFTs AXTG Aug 11, 2022 10:15 AM

PURA Announces New Development Expanding Cannabis Market Opportunity PURA Aug 11, 2022 9:34 AM

Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis KTTA Aug 11, 2022 8:35 AM

SinglePoint Acquires Frontline Power Solutions, a Multi-State Licensed Energy Services Company SING Aug 11, 2022 8:30 AM

Pacific Booker Minerals Inc. Announces AGM Results and Project Update PBMLF Aug 11, 2022 7:30 AM

GALILEO ANNOUNCES THE START OF REVENUE GENERATION AND ITS EXPANSION PLAN. MDRM Aug 10, 2022 3:23 PM

ResGreen Powers Up - Introduces Wireless Battery Charging for its Fleet of Mobile Robots RGGI Aug 10, 2022 10:53 AM

Kona Gold Beverage, Inc Signs New Distribution Partners in California, Illinois, and Nevada KGKG Aug 10, 2022 9:00 AM

Investing in Quantum Computing: What Every Investor Needs to Know GOOGL Aug 10, 2022 8:45 AM

New Drugs in Pipeline for Hypertension, the Silent Global Pandemic BMY Aug 10, 2022 8:45 AM

Mill City Ventures III, Ltd. provides 2nd Quarter Fiscal 2022 Guidance Revenue Increased 83% year over year and 83% for 6-month period MCVT Aug 10, 2022 8:44 AM

Branded Legacy, Inc. Cancels Another 60 Million Common Shares BLEG Aug 10, 2022 8:30 AM

Defiance Discovers Blind Silver System At Lucita DEF Aug 9, 2022 10:31 AM

USMJ Announces New York Adult Use Cannabis License PURA Aug 9, 2022 10:21 AM