Seven journal publications have challenged the legitimacy of any conclusions for NWBO's P3 trial due to the complete redo of the protocol when the trial was virtually done.
The bias introduced into the trial is obvious and the FDA will see the complete violations of FDA Guidance. The FDA ECA Guidelines require that ECA be developed and approved PRIOR to the start of the trial, not when the trial is virtually complete. The ECA design has many data omissions that would be required to match samples.
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