NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Mike, even if you're right about a referral to the CHM it doesn't mean they'll say no. I certainly have no knowledge of how they operate, but it sounded to me like they can listen to the arguments from both sides. If permitted, they could be shown evidence from early phase trials indicating that 50% or more patients could have 5-year survival with the inclusion of other therapeutics. If permitted to see such evidence, would they really be willing to delay the vaccine by several years by demanding additional trials.

I'm of the belief that all the regulators have some knowledge of what other small trials are showing. I wish they could take dynamic action and simply approve, but they won't. I do believe they'll act positively when they receive submissions to act on. I still believe we need the EDEN approval to make such submissions as approvals with production limited to 1000 patients a year make no sense for anything larger than the UK, and even there the EDEN will be needed in the not that distant future.

I still believe the likelihood of approval is well over 90%, the real question is, approval for what?

Gary