NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

HL,

I really don't believe that the regulators will delay approval, but they'll not be granting it until they're certain that at least initial demands can be met by the production facility they're approving for initial commercial production.

With the exception of the U.K. I believe it all ties to FlaskWorks approval. If the company didn't believe that could happen in a reasonable period of time I believe they'd be looking to contract for the use of every cleanroom that they could put under contract including new cleanrooms built to meet their needs. I don't believe this is the case, so I believe that FlaskWorks units will be approved this year, but perhaps too late to also gain approval this year.

I believe the regulators would have to be blind not to know that approving DCVax-L doesn't just move the needle from 5% to almost 15% survival at 5 years, I believe they know that 50% can be achieved with off label use by Keytruda and other products.

Gary