ATLnsider, regulators give input, but not buy in. All we know is that NWBO spent a lotalota time on the new SAP, and certainly went back and forth with the FDA and other regulators on the details in the new SAP. We also assume the SAP is the same one submitted to all 4 regulators.
ATLnsider, thank you for finding this info about the new endpoints of the EU clinical website. I was having a lousy day post surgery and when I started reading the EU details, the pain magically disappeared!
Obviously, I need more of this sort of medicine.
NWBO, do you hear me??