Does anyone know off the top of their heads how special the Special Protocol Request is, or is it something that is often filed with final phase 3 protocol paperwork to the FDA? I like the fact that Leo provided a little insight as to why they are doing it though. So I am hoping that it is in fact an out of the ordinary step, but this is my first rodeo going into a phase 3 trial, and I am still learning. Plus I dont have the time this morning to look it up on the FDA sites. Go CTIX!!
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