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Re: DewDiligence post# 11987

Monday, 06/23/2008 11:53:05 PM

Monday, June 23, 2008 11:53:05 PM

Post# of 19309
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.


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