Thursday, December 02, 2021 2:22:49 PM
The interesting issue is the monkey wrench thrown into the gears by FDA. Their ideal candidate is being held back by their own slowness to accept necessary changes to validate effectiveness of immunotherapy effect, a defect in process that they have been well acquainted with for many years. FDA really looks foolish when they want to ask a company to move into hyperdrive when the chains placed on that company by FDA’s own process keeps them in first gear. I think things are being worked out quietly through available channels by asking NWBO to wait while the paperwork and logistics are being finished up on their end. By the way, has anyone actually produced definitive proof that a conceptual on demand agreement is no longer in place with Charles Rivers Labs/Cognate and if one existed and was not completely terminated but no current production is being done that this agreement must be updated rather than just production itself? I don’t remember seeing this if shared. By the way, even you admit that Charles Rivers Labs/Cognate could be worldwide ready very soon as they already have certification in US, Europe and I assume CRL has rest of world certs pretty much in place too. Best wishes.
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