Are you an optimist? "In the [complete response letter], no new clinical studies were requested."
Or a pessimist? "However, in the event that any of the [Food and Drug Administration] concerns are not alleviated, additional clinical studies may be required."
There was something for bulls and bears alike to love about the FDA turning down VIVUS'
Qnexa is a combination of phentermine -- the phen in fen-phen -- and the active ingredient in Johnson & Johnson's
The bigger issue could be the FDA's request to determine whether the elevated heart rate seen in patients taking Qnexa translates into an increased risk for major adverse cardiovascular events such as heart attacks and strokes. The company does have two-year safety data to share with the FDA, but whether that'll be enough to satisfy the request remains to be seen. Proving that a drug doesn't cause heart problems can require a large trial. Check out the size of the phase 3 trials for GlaxoSmithKline's
VIVUS seems to think the FDA's request is fairly minor. The drugmaker plans to respond to the FDA in about six weeks. Compare that to Arena Pharmaceuticals
Where does the pair of rejections leave Orexigen Therapeutics
Investors in VIVUS can only hope that those hoops aren't too numerous.
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. GlaxoSmithKline is a Motley Fool Global Gains selection. Motley Fool Options has recommended a diagonal call position on Johnson & Johnson, which is a Motley Fool Income Investor pick. The Fool owns shares of GlaxoSmithKline and Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Fool has a disclosure policy.