Replies to post #596752 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The FDA has never said that, thats a blunt falsehood. Its not for nothing that you never quote FDA regulations with a link. Why is that?

I have quoted the FDA guidance plenty of times. Once more:

Overall survival should be evaluated in randomized controlled studies. Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival.

You can also see on page 5 the table of recommended oncology endpoints shows OS in a randomized trial only.