Replies to post #520305 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

inferred, implied. Does that mean that investigators had to know the secret handshake to know if the trial was adaptive?

[HyGro]

You can't "infer or imply" adaptive trials. Read the FDA Adaptive Trial Guidance -- the NWBO trial doesn't meet any of the requirements.
The trial has to be designed as adaptive and approved BEFORE the trial starts as such -- NWBO certainly didn't do that. It requires and interim review and decision tree on adapting the trial -- NWBO certainly didn't do that. NWBO did all of the protocol changes AFTER the data gathering had been gathered.

https://www.fda.gov/media/78495/download