When a drug is in U.S. clinical trials they can be considered for compassionate use. NWBO actually sold a few doses, not enough to provide any meaningful data.
Direct is NOWHERE and has no bearing on DCVax-L review.
FDA and MHRA do not jointly “approve” drugs or trials, but they have formal frameworks to share data, align standards, and let MHRA rely on FDA (and other “trusted” regulators) for both clinical trial oversight and post-trial commercial approvals. Each still issues its own independent decision.
FDA already provided NWBO feedback on that's why NWBO passed on filing with the FDA.
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