So much for a fairly quick resubmission of VIVUS'
Topirmate -- the active ingredient in Johnson & Johnson's
The delay itself isn't that big of a deal. It's not like VIVUS announced a lengthy clinical trial. But the 15% drop today still looks justified because the news adds a layer of uncertainty to Qnexa's likelihood of approval:
- Exactly how long is this going to take?
- What happens if the databases aren't sufficient to answer the FDA's questions? I'm not sure how one could ethically test this in a clinical trial.
- If they are acceptable, what level of cleft lip is acceptable? Certainly it's lower for a diet drug than for a migraine treatment.
- What will the FDA do with this information? Limit Qnexa use to just men, cutting the market in half? Require regular pregnancy tests, which could indirectly lower sales?
Until these answers are known, Qnexa is looking a lot like rival lorcaserin from Arena Pharmaceuticals
For now, Orexigen's
See a stock that's had a big run up? Jim Royal explains why you may want to avoid it.