Wednesday, February 10, 2016 6:02:26 PM
We haven't heard anything yet on the status of Fast Track or Priority Review.
I was just pointing out that QIDP related speeding up also occurs during drug development. I have no idea whether or not Fast Track (assuming it was applied for) would reduce the SPA timeline requirements.
"I think the QIDP related speeding up occurs later, during the FDA's review of the New Drug Application."
http://www.fda.gov/ForPatients/Approvals/Fast/default.htm
As always, in my opinion only. Do your own due diligence!
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