Replies to post #139205 on NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

Flipper, since you are looking at ACT iv:

An independent imaging review committee (BioClinica,Princeton, NJ, USA) assessed post-operative and postchemoradiation brain MRIs, and retrospectively classified patients as having either MRD (<2 cm² of residual enhancing tumour on post-chemoradiation imaging) or significant residual disease (SRD; ≥2 cm² of residual enhancing tumour on post-chemoradiation imaging).

my question: to what extent do you think they used that post chemorad imaging to exclude progressing patients.

The protocol should shed light on that. The paper says:

The study was compliant with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethics approval was obtained at all participating centres and all patients provided written informed consent. The full trial protocol can be found in the appendix.

However, the full protocol can not be found in the appendix.

When you look at the KM curves for PFS for the SRD group you see mPFS of 3.7 months. That makes me question the methods they used to exclude progressing patients from randomization. They say:

Exclusion criteria were disease progression during chemoradiation, ....

Do you agree that it would be important to understand exactly how that was determined? (to spell it out: psPD is false progression generally AFTER chemorad. Sometimes many months after.)

Finally, where/when did Dr. Liau say:

Dr. Liau wants to compare blended Rindopepimut with blinded DCVax-L trial. Wonder why?