There have been many posts here that claim that QNexa doesnt have anything and that one could always just take a combination of generic phentarmine and generic topiramate from the market and equate QNexa's results..

Untrue.

QNexa's formulation is an instant release phentarmine and a controlled release topiramate with patents for Vivus. No doctor can just prescribe a generic phentarmine and generic topimarate in lieu of QNexa.

Next...understanding Phase III data. My understanding is that the Phase III data just announced is under a Special Protocol Assessment (SPA) from the FDA. Please expand or clarify this long timers.

This is significant because a SPA study indicates that the study design and primary endpoints have been blessed by the FDA going into the study. What that would imply is a relatively smooth approval...

Next for QNexa..as the phase III results have shown, QNexa also reduced co-morbidity factors such as high sugar and blood pressure. THis is significant because QNexa is currently in Phase II studies as a diabetes treatment. Very significant because if a drug is potentially approved for both diabetes and anti-obesity...it could be a blockbuster in a class all its own.

Finally, Avanafil results are due soon. You may recall that Vivus was one of the first ED drugs on the market with MUSE in 1997 before Viagra killed it in 1998. Well they are back with a Viagra competitor - the big news here is that it could have data that allows men using nitrates to use it, that has no restriction on food or drink and provide a quicker response. It could be a strong contender for 2nd or 3rd place in a $5-7B market in the US alone.

This is a great company that (1) got killed by Viagra and (2) is back with two great drugs - QNexa and Avanafil in Phase III.

Finally, the rest of the pipeline - QNexa for diabetes and ...drum roll....HSDD (a testorone based treatment for women for low sexual desire) drug Luramist which the company is currently working with the FDA on to conduct a pivotal study. The HSDD market is a brand new untapped market.

Competition:
ARNA (phase 2): 3.6% placebo adjusted weight loss. Relatively safe with some issues (unclear)...phase 3 will clarify.
OREX (phase 3): 4.2% placebo adjusted weight loss. 7 serious cases of side effects including seizures.
VVUS (phase 3): 10-11% placebo adjusted weight loss. Very safe..reduced co-morbidity factors including diabetes and blood pressure. SPA study.

VVUS has such a lead here that it would behoove the FDA to approve VVUS and handily reject OREX and ARNA. The FDA will not approve all three of these drugs.

High hopes for VVUS. Look for $20 by end of the year. If we get Avanafil data, we could see a higher number into the $30s. Premiums for a buyout would depend on the then current stock price.

Catalysts: Avanafil phase 3 data, Partnership for QNexa, study parameters with FDA for Luramist, QNexa for diabetes additional data, additional safety data for QNexa expected Dec 2009.