Replies to post #508754 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Which doctor, scientist or professional predicted approval of DCVax-L in less than six months?

[HyGro]

NWBO hasn't filed an application for approval with any regulator yet. FDA takes 2 months to review application for completeness and give a PDUFA date. The review process takes from 6 months (if expedited process) or 10 months.

Add the slow pace that NWBO operates in for preparing this application, it is likely not going to be hearing deep into 2023 and perhaps into 2024 for hearing a final response. That is off course if FDA accepts the application in the first place.

They have a lot of explaining to do
- Issues that caused the stoppage of the trial
- Confounding of the PFS and why it caused NWBO to toss it out
- Confounding of the naive OS data and why it is valid for any conclusions
- Tossing out control and the external comparator development process
- Data dredging of the naive GBM control patients into a recurrent GBM OS arm
Going to be a challenge to prepare cogent analyses for each on of these potential issues in this trial.