NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

This isn't really how things go, though. If you have a strong signal that your drug can take long-term survivorship from the 5-10% range into the 15%-20% range, with statistically significant improvement overall, then from an efficacy standpoint, it's pretty well a lock.

You can look at the many, many randomized positive checkpoint inhibitor trials to get a sense of this. Lots and lots of patients do not respond, but the big picture is that the therapy improved outcomes in the experimental group compared with the control group, and that's usually enough.

It's possible there are questions about the control used here, but I feel that the most dire consequence this should lead to, in my opinion, is requiring another confirmatory trial with an enrolled control group, not an external comparator.

Essentially an accelerated approval, which we've seen many of in the US on the basis of promising single-arm trial results.