Sorry, first FDA guidance requires a PROSPECTIVE ECA done before the trial starts. NWBO's ECA was post hoc, AFTER the trial was virtually complete. That violates the new FDA Guidance just on that point. Then there is the significant bias in the ECA selection.
ECA selection showed significant bias. NWBO treatment arm benefited from a screener that requires complete or near complete resection while the ECA trials accepted biopsy only patients that had significant tumor remaining. Complete resected patients have significantly higher survival rate versus biopsy only regardless of treatment.
In addition, NWBO patients received significantly higher dosing of DCVax-L (90% had crossover dosing) while comparators did not have that benefit.
These are significant causes of bias in the trial and the reason to question the validity of any conclusions from the trial.
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