NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

There was no "cherry picking" and in fact not all patients are fully resected in DCVax-L's trial and the residual disease factors appear to be similar.

Most all clinical trials "cheery pick" patients. For randomized trials this presents no issue as the comparison is against those with the same entrance requirements. For cross trial comparisons one now has to worry about differences in patient populations caused by the difference in entrance requirements.

There is no question that a substantial difference exists wrt tumor resection. -L required intent for near total resection,. ECA trials any partial and all but one allowed biopsy only.

It is well known that better resection improves OS. There is almost no data on extent of resection in the ECAs. Only one trial reported it, and that only on over/under 1cm^3. residue. And that subset raised a huge flag. The minimum residue patients (where the resection would be comparable between the trials) showed no -L benefit. The significant residue patients (where the -L would have less residue) is where all the benefit showed up.

That a concern with this exists is clear. That neither the May 10 data nor JAMA Oncology paper tried to explain it with far better data that we have is "telling".