Hard to tell if the drug really works. NWBO has stated repeatedly that the OS data is confounded making it suspect. Them the external comparators have been found to have bias in favor of the treatment arm too (FDA Guidance documents). So with skitchy data, it is questionable how this will be reviewed by the FDA.
Even NWBO says so: "There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."
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