NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Learn anything interesting from the session on using external controls?

sentiment,

A lot of good Presentations and Panel Discussions.
I find John Sampson’s presentation very interesting.

John Sampson, MD, PhD, said : (recently)……….we ( =John Sampson and his team) did have a very good conversation with the FDA and they are going to allow us, for our Registrational Trial here in the US, to use.... external controls. (MDNA55 Planned Phase 3 Trial Hybrid Design with RCT and External Control)

“Most of our power for the study in the SOC arm was going to come from what they (FDA) calling External Controls…….”

at the end of the presentation:

3:30-3:40 pm Point/Counterpoint: Why Current Standard of Care for
GBM is Not a Major Impediment to Progress
John Sampson, MD, PhD, Duke Cancer Center

https://www.soc-neuro-onc.org/UploadedFiles/SNO%202020%20Think%20Tank%20Meeting%2011-2-2020.pdf

https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2020/MDNA-Planning-for-Innovative-Hybrid-Registration-Trial-for-MDNA55-article/default.aspx