NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

I joined the talk a bit late, but here are my impressions of LL's talk at the University of Miami (3/31/2022, 5 to 6 PM EDT):

1. She gave reasons why PFS is not the best end point indicator in GBM trials.
2. Essentially said that OS is the best indicator.
3. Said that it is not ethical to push patients into control arm in GBM trials.
4. Thus, the trials become single arm trials because of cross-over. Hence the need for comparison with ECAs.
5. Quoted the recent (February 2022) FDA paper on the ECAs.
6. Went more in-depth with the various ECAs and their stats. Apparently these are being used in the paper.
7. Kept silent on the P3 TLD and the journal paper. Probably was asked not to broach that topic.
8. No questions later on the P3 TLD later from the audience.
9. Talked on methylated vs. unmethylated, idh-mutation, ...
10. Emphasized that the GBM patient population size is small compared to the other types of cancer.