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07/13/23 3:13 PM

#609414 RE: Maverick0408 #609409

Maverick0408,

Regulators need to have THEIR product release requirement processes in place for the application to be approved and those processes need to be submitted in the MAA/BLA application in order for that to happen. If the oversight processes are not defined correctly by regulators to make high volume personalized treatment readily available to meet expected demand then THEY are the ones holding up the process. That NWBO won’t say anything about this is more than obvious except to those choosing to blame the company because of the silence and delay. Best wishes.