NWBO has stated that the made the trials "at risk"-- that means no regualtors have approved the revised trial design. FDA Guidance says companies need to submit the changes, but FDA doesn't approve it. Same with MHRA.
NWBO has no confidence of the new trial approval until they submit their application for approval. THEN FDA will hammer them with the numerous guidance violations and the endemic bias of the revised trial with post hoc ECA (requirement is pre-trial approval). That's the facts -- call it what you want.
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