NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

An interesting confounder:

Say over 80% of patients in the Direct trial experience significant tumor necrosis of their primary injected tumor, and also t-cell infiltration, as well as some of both in nearby and even some distal non-injected tumors. These patients are ceased from therapy but continue to be monitored after all 6 injects. They cannot enroll in the Ph II leg.

Suppose many of these, seeing that their primary tumor is filled with necrosis and they have achieved stability of disease but distal tumors appear little affected beyond being stymied, decide to enroll in other clinical trials. The most popular of these currently being checkpoint inhibitor trials. Say many do enroll, and the combined therapies prove synergistic. This will confound DCVax-Direct results to the positive on follow up.

Of course normally this would be noted in academic study results, that these patients sought and enrolled in alternative therapy after their DCVax-Direct course was through, but that will most likely go without saying (literally) when management portrays Direct results from this trial in a year to 18 months from now.

I'll throw out a prediction that many of the 40 will do just that (and perhaps a number in the Ph II leg as well), and their results after 2 years will exceed those who stuck with Direct alone (which may be the minority). That may be the first data used to suggest this combination therapy be explored in larger studies.

$.02