This one may hurt.

Implications: It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in the near and mid-term future. This does not bode well for Sanofi, who will not have to regroup and pray for success with son of Amiodarone.

Analysis:  The decision by the advisory panel to deny rimonabant (14-0) was certainly a surprise to Sanofi and the magnitude of the majority shows how concerned they are about the psychiatric implications. I personally feel that the level of apprehension is unwarranted on the basis of the data. However, I would guess that they are worried that if approved even a black box might not be enough to prevent use in susceptible individuals. I am upset that our access to this drug will be delayed (if not prevented), because it does have good data on metabolic benefits in a very at risk population. It seems to me that the overall impact on patient health would have been for the better if this drug was made available.
I am amazed that Sanofi seems prepared to go forward with their plans to train their sales staff on this drug within the next several months. They now have limited prospects and a lot of disappointed staff and stock-holders