NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

marz, my guess is that the validation work addressed issues raised by the inspectors, but it’s anyone’s guess. There have been guidances issued by regulators that updated Process Validation since manufacturing for the clinical trial concluded. Part of the revisions involved methods to assure continued operational quality through continuous verification. Regulators now recognize that good process control, monitoring, and process verification through real-time-release testing can assure that a product can be found acceptable prior to the conventional quality control measure of final product testing. The agencies expect all legacy processes to be validated, and there may have been some gaps in the new SOP’s.