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Re: Steady_T post# 457263

Sunday, 04/21/2024 1:57:16 AM

Sunday, April 21, 2024 1:57:16 AM

Post# of 462171
I know the submission that NWBO made to the UK was 1.7 million pages and their production facility was approved prior to the submission. I'm not saying the same would be true here, but the regulators do seem to take an ungodly amount of paperwork if you don't want questions, and further delays because you've covered all the bases. If they were submitting a BLA to the FDA it would have to include information on commercial production and I expect most of what's in the UK submission would be included, so it would probably be larger.

I would suspect that many of the 1.7 million pages will never see the light of day, but if there are questions on key pages the answers can be found somewhere inside those pages.

Gary
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