NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Flipper,

I very much appreciate what you've said about DCVax-Direct, I do have one question. I gather it has been improved, I'm just questioning whether the regulators will allow it to go directly into a Phase 2/3, or if they'll insist on a Phase 1 with the improved vaccine.

I agree with you that getting DCVax-L approved, so no questions will be asked about that is smart at this late point in it's development. I don't think it would have mattered 5 years ago, but we're so close that it's better to wait. I would hope that DCVax-Direct can initially be made using the FlaskWork device, that would eliminate all discussion about it's use in making the product post approval.

I would expect that if we establish a BP partner that development of DCVax-Direct could be substantially faster than without them as they should be able to gear up for a more aggressive trial, use far more clinical sites to gather data faster. No doubt, remaining independent NWBO should be able to fund such a trial with dilutive funding, but staffing would take more time than if we have the resources from a BP partner available to us.

Thanks for all your efforts,

Gary