NorthWest Biotherapeutics Inc (NWBO)

[gnawkz]

Fair, I just think it is too difficult to present any PFS with all of these different cancers and many that have metastasized.

Your point is well taken, but to share PFS data at this point will create a lot of confusion. Folks with limited knowledge about the subject will just execute an overall median and come to a conclusion that the PFS is horrible when it really is not and depends on the cancer / treatment / dosage / schedule / metastasis / etc ...

In addition, the Phase I Direct trial did not specify that patients admitted had to have completed previous treatment within a specific time frame like DCVax-L trial required.

Thus, these patients could have already started progression right before the injection or right after the 1st injection. No controls were established within the Phase I clinical trials to test for PFS nor was there a need as it was meant to test for Safety and Tumor Shrinkage. Thus, even if a PFS metric was provided, it could not be accurate. There was no way to know when the start was ... especially if the most recent treatment of the Stage IV cancer was 6 to 9 months back.

What NWBO learned from this trial was:
1. It was Safe
2. The procedures utilized in Phase I does not appear sufficient to pursue a RECIST defined response across all solid tumors. Does not mean it cannot work for specific cancers given enough time.
3. There are several areas for improvement in terms of dosage / schedule / activation
4. PFS and OS endpoints might need to be considered if a RECIST defined response is unlikely to occur.

Apologies on the above, should have shared all my thoughts. I was typing fast and had to run somewhere.