Qnexa New Drug Application

[mbouris]

Great news for those following Qnexa. Vivus (of Mt. View, CA) just announced that they have submitted their application (NDA= New Drug Application) to the FDA for approval to market Qnexa. The "bad news" is that it is difficult to predict just when approval might be expected. It could be months, or even years (if more studies and information is requested by the FDA) before a judgement by the FDA is made. Their press release and Form 8-K are available on Vivus website.

[mbouris]

More interesting news from Vivus by way of another SEC 8-K (and press release). This time regarding the success of phase II trials of Qnexa used as a medication for Obstructive Sleep Apnea. Of interest to this board is that during the 28 week trial, the average weight loss was 10.2% of body weight of those using Qnexa vs. 4.3% for the placebo patients. As mentioned elsewhere, Vivus sent the NDA (New Drug Application) to the FDA late in December of 2009. Hopefully, approval will occur sometime in 2010.

[mbouris]

More good news about Qnexa. The FDA just "accepted" the NDA (New Drug Application) from Vivus, the manufacturer. The FDA projects that it will complete it's review by October 28, 2010. While "just another step", it is a significant step toward approval...hopefully by late October!

[admin]

Definitely a good step towards acceptance, no home run yet but a good step non the less