NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

While I agree with that, I'd actually do a Phase 4 where all uses of the vaccine, and all newly approved products, are tracked until the FDA is completely satisfied with their safety, and efficacy. Perhaps more importantly, Drs. would be asked to discuss successes in which they tried new therapeutic combinations and protocols that could assist others.

I believe that very few products are limited in use to only the protocol used in the clinical trials. Dr. Liau, beyond any doubt, is trying new ideas to increase the effectiveness of DCVax-L and that's why Poly-ICLC, etc. has been added. Her goal is curing all with brain cancer, so she'll keep working to improve on the gains she's already reached.

Hopefully all the regulators will begin to work together more, and do things more dynamically. New products shouldn't take one to two decades or more from genesis to approval, but they do. DCVax-Direct is clearly the victim of insufficient funding and it's sad that some agencies didn't offer NWBO a means to keep it in the clinic.

Gary