We have heard that the FDA has delayed its final verdict on Qnexa until July. We do not think that this decision should be viewed in a negative light. All of the signals are that Qnexa will be approved by the FDA. There are even rumours going around that they are under pressure to approve an anti-obesity medication and, as Qnexa is the most effective (and potentially the safest), then this would be the one to go for.
The reason for the delay is quite simple. The FDA has only just received the Risk Evaluation and Mitigation Strategy for Qnexa and they want time to consider it properly.
We are still of the view that Qnexa will be licensed in the US and Europe in 2012. This of course leaves open the possibility that Lorcaserin will be approved before Qnexa. Lorcaserin is less effective than Qnexa in term of weight loss achieved and there are some vestigial concerns about side effects given that it is from the same family of compounds as Fenfluramine, which had to be withdrawn a few years ago because of heart valve damage. Both may get the green light but if we had to choose just one, we would go for Qnexa.