Replies to post #511933 on NorthWest Biotherapeutics Inc (NWBO)

[Roman516]

The FDA guidance, Clinical trial endpoints, approval of Cancer drugs and Biologics

With respect to NWBO and DCVAx=L
ALL of these endpoints are accepted for FDA approval consideration.
- Overall Survival, OS results surpass PFS predictions
- Disease-Free Survival (and Event-Free Survival), Survival better than current SOC
- Objective Response Rate, at least 2.5X that of present SOC
- Complete Response, Same as above and potential longer timeframes later
- Time to Progression and Progression-Free Survival, again at least 2.5X that of present SOC
- Time to Treatment Failure at least 2.5X that of present SOC

Based on the real facts about DCVax-L, this is looking better than the current SOC.
Looking forward to more good news as NWBO moves forward

[Dr Bala]

Thanks, HyGro. This therapy will be approved based on the outstanding results on the first endpoint in your post.