NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

Say that your scenario proves correct " 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", and that as many as 40 will decide to enroll in other clinical trials (ie checkpoint inhibitor) after completion of DCVax-Direct (phase I).

I dislike the idea that this would then make if very difficult to discern the effectiveness of DCVax-Direct on a standalone basis. If these 40 patients show dramatic improvement, then the argument could be that they improved due to the subsequent treatment as opposed to the DCVax treatment. It thus makes the initial efficacy results more inconclusive.

On the other hand, say that DCVax-Direct shows similar effectiveness in humans as in their animal trials .... which, after time, eradicated the tumors. Given a chance (ie sufficient time after their 6th injection) .... what do you currently estimate the odds that Direct could be the full solution .... whereby patients do not need to go enroll in another clinical trial afterwards?

I suspect that if NWBO concludes that it would be beneficial or synergistic to explore combination therapies ... then it would be like starting all over at the beginning of a new phase I trial to test the combination? In that instance would the Direct trial continue on a standalone basis?