NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm saddened by my belief that in fact the 4 regulators all have a pretty fair idea of exactly what happened during the trial, they know the vaccine works and they've allowed the change to the goals because of what they know. What's sad is that they cause years to be wasted as the company must go through all the hurdles they put in their way before the vaccine can be approved.

I don't say this specific to DCVax-L, I believe that much the same is true of all sorts of products which the regulators eventually approve. I'm suggesting that knowing what they do, they could approve without forcing the sponsor to take the years and millions to create the BLA or NDA and wait for approval. Early approvals could easily be followed by a Phase 4 in which every use of the product needed to be reported so the regulators could be certain of no unexpected problems.

I don't doubt that many products are a much closer call, and all the documentation, time, and money is needed, but I believe the FDA does know of superior products in the pipeline where dynamic action could save many lives and lower costs dramatically, but the regulators simply do things by the book, they fight not to be dynamic.

Gary