>Sorry to perpetuate this, but what you said simply means that the pros were wrong prior to the AdCom, ain't they?<
Not at all—it means the advisory panel was wrong.
This is a presumptuous and dangerous line of thinking.
Presumptuous because the advisory committee consisted mostly of people who have spent their life doing research in the area while who knows what the so called "pros" on this board do. In any case, the AC's role was only to give advices to the FDA, not to predict their action. As such, they could not be wrong.
Dangerous because this line of thinking implies that the so called "pros" here could accurately assess drug efficacy from published data and, further, predict what the FDA would do. In fact, in the other case for PC recently dealt with, Satraplatin, the "pros" (or perhaps just "pro"?) were dead wrong with their continuing hype of the hazard ratio in the progression endpoint over the mediocre median difference and survival data.
The main lesson to be learned in both cases was that even with much available publication, there were more hidden information than known before the respective AC's.
