On priority review, is there any possibility of hearing the FDA's decision on that before you submit the last BLA module or will that necessarily wait until the last module goes in?
3/6/08 CC question
Geoffrey Cox...
Again, that's a good question. My guess is, to be quite honest, that we will hear sooner than submission of the last module. That's our expectation. But, again, we've heard nothing back from the FDA which is nothing bad in that respect. I think there is a normal time pattern for hearing with regard to submission proprietary review. But we're hoping that we will hear over the next few weeks in that respect.
"Ninety percent of this game is half mental." Yogi Berra