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Thursday, February 17, 2022 3:37:08 PM
Do you, or anyone else, know how much can be found to be in common between what's needed by the U.K. and the BLA required in the U.S.
I was hoping that if the BLA required by our FDA was completed it would satisfy the paperwork required by all of the regulators. It sounds like the U.K. will accept something less, but if the BLA would do the job for all, I'd hope the company is stressing getting it done.
I still feel the acceptance of the FlaskWork unit is the key. If the company is prepared to make thousands of them, and St. Gobain Glass is capable of delivering tens or hundreds of thousands of them, all production questions can rapidly be answered. The most recent photos of the unit clearly show design changes, hopefully we've now evolved to the point that this will be the production model, or very close to it. Once approved I believe they'll have the capability of mass producing sufficient units that by the time we have an approval, we have many devices ready to make DCVax-L.
Meanwhile, hopefully Sawston will rapidly build up from it's first patient to receive vaccine to reaching it's capacity of roughly 50 patients a month that are receiving it under compassionate use.
Gary
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