NorthWest Biotherapeutics Inc (NWBO)

[reachjo]

The author, Z Sun, that published on seekingalpha needs to seek an education. Z Sun’s statement incredibly irresponsible. If a GBM patient who was considering DC Vax through compassionate use read that, they may give up.

Interim analysis (Example: O’Brien-Fleming Boundary) is a point where investigators can stop a study based on early analysis of the data. If there is a clear benefit or harm to patients investigators can halt the clinical trial. However, O’Brien-Fleming Boundary would not be considered here because the study was designed so that if anyone in the non-treatment (SOC) group progressed, they would receive active (DC Vax) treatment. So harm is mitigated. If DC Vax were showing benefit, there would still be no reason to stop the study because 1) DC Vax is available to the world through compassionate use 2) As stated above if progression in the non-treatment (SOC) group progressed, they got DC Vax. In essence, any patient in the study would have access to it and anyone in the world can get it. So, Benefit is mitigated.
Finally, this is the first and longest clinical trial in the history of GBM considering pseudo progression. It is literally data no one has ever looked into before. It’s ground breaking to say the least. Given that benefit and harm are mitigated there is no reason to stop the trial and any ethical investigator worth their salt would realize this and see it to the end.

Z Sun’s article is both irresponsible and ignorant.