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Re: lrdpdx77 post# 423747

Saturday, 12/04/2021 3:09:08 PM

Saturday, December 04, 2021 3:09:08 PM

Post# of 818847
I believe it's clear that CRL will be producing DCVax-L for at least 5 years after approval. The question I'd ask today is, has the FDA already approved of the facilities where it will be made.

We've all been concentrating on what's happening in Sawston, it's important to know if CRL must undergo a similar inspection, or is it already qualified. Either way I don't believe they'll have much trouble, but it would be nice if nothing more needed to be done there.

I do believe that when the FlaskWork device is authorized contractors like CRL will need to negotiate for it's use. I would suspect that it would be a good time to also negotiate for an extension to the contract. NWBO ought to bring in substantial funds in such negotiations.

Gary
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