So what is it that you disagree with? The fact that the CMC problems did not affect the efficacy decision of the FDA? I disagree with you because human nature says that one decision affects another in these games. If the FDA was convinced that the CMC issues were going to cause a delay of a year or so, then it is easy to see why they would require further efficacy data as well since they would not at that stage feel guilty on account of delaying the treatment from patients, and additional efficacy data is always a good thing...
Let's think this through. Suppose that the FDA did not believe that there was sufficient evidence that Provenge works, then it was clear that new efficacy data should be required. The CMC issue would have had nothing to do with it. This decision would be a rational one.
Now, suppose that they actually believed that there were substantial evidence that Provenge works as the vote of the AC showed. But because of a CMC issue that could be resolved in a few months or a year and because "additional efficacy data is always a good thing", human nature then let them require new efficacy that at the time was estimated not to be seen for 3 years. That's at least a couple of years to three years of waiting while people are dying. Given that they always had the ability to withdraw approval on new negative evidence, this decision would be not just irrational but also inhumane.
Invoking human nature, etc. to make a point basically shows that you are thinking about this based on a system of belief rather than reasoning about it based on the facts at hand. I fully understood where your were, hence, my previous parting comment "Believe what you will".
