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Re: NeWBrO post# 656954

Monday, 12/18/2023 1:50:47 PM

Monday, December 18, 2023 1:50:47 PM

Post# of 724179

Good to see CRL Memphis has EMA / FDA compliance experience !


NWBO has the exact same ability to negotiate a contract with CRL as anybody else does. Maybe even less based on their prior history of not paying Cognate once LP sold it.

Per CRL others have been reserving capacity well in advance of a possible FDA approval to insure they have access to it.Need to have all set up for an FDA inspection, and that can take a long time (many recommend a year prior to the submission).

And do not assume CRL has any ability in place to manufacturer DC-L. They last made it 8 years ago with equipment that was who knows how old.
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