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skitahoe

07/07/22 8:56 PM

#493338 RE: Horseb4CarT #493310

I wasn't suggesting that they don't accept meds made elsewhere, they do, but they insist on being the ones that inspect the manufacturing plants to assure they meet their requirements.

In saying I didn't think they'd accept Sawston, it's not because they wouldn't want vaccine from there. I may be wrong but my thinking was the full capacity of Sawston was intended to be the supplier of DCVax-L to the U.K. and the rest of Europe. If I'm wrong about this Sawston could be what NWBO proposes for U.S. production. If that were the case, even with approval by the U.K. the FDA will insist on their inspectors certifying it, and they may insist on changes to a facility that the U.K. already approved.

I may be wrong, but I still believe that NWBO and CRL will announce a continuing relationship when the time is right, and it will utilize the FlaskWorks units for production for the U.S., and perhaps Canada. I suppose the question is, has CRL already developed facilities that are ready for FlaskWorks units and all they need it to add the units and you have a working production plant.

Gary