NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Druggie, and I believe others, have suggested that NWBO is going for a tumor agnostic label in the UK submission. I'm wondering if anyone thinks that the documentation for that will come out of only the data developed in the Phase 3 trial, or if they can incorporate data that's never been previously revealed on patients with other cancers who were treated under compassionate use in the UK. I know we've heard about a few of them, but I gather that there are many more that could be cited.

If it's true that NWBO is shooting for a tumor agnostic label, and gets it, even if confirmatory trials are required, the demand for DCVax-L in the UK alone could be well beyond what Sawston can deliver without the EDEN device. It might be questioned if NWBO is simultaneously going for EDEN approval in the UK.

There is no doubt that NWBO is pushing tumor agnostic, just the pictures of their booth at SNO made that clear, and I'd bet that ASCO or any other conferences that they exhibit at from here on will be very similar. I believe that other products tried in pancreatic cancer alone that were approved were essentially given tumor agnostic labels, if that's the case, I don't know why an equal case shouldn't be accepted for GBM.

Gary