Replies to post #289803 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-modernizes-clinical-trial-designs-and-approaches-drug-development-proposing-new

[biosectinvestor]

And also:


https://www.federalregister.gov/documents/2019/12/20/2019-27524/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-draft

[VuBru]

Not sure they used an adaptive design (e.g., enriching the trial for responders in mid-stream) - it seemed like a pretty traditional trial.