Tuesday, April 27, 2010 9:21:12 PM
I believe that the new review team took 2 months to look over all the prior submissions and concluded with 18 questions plus a radiologist review. When all this was resubmitted the FDA only needed to cross the T's and dot the I's. The fast track program allows Dean to communicate by phone and resolve issues in a fashion that would expedite the process.
If the review was submitted and accepted then I personally see no reason that we should not get approval this time. This is only my opinion and I am sure as many posters on board believe that much of the PPS deterioration has been because of PPM shares and shorters taken center stage.
The day is approaching quickly and I would not be at all surprised to see the PPS climb as we get closer to the targeted date.
GLTA
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