FDA won't accept NWBO P3 trial ECA:
FDA Historical Comparator Guidance:
"Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial. Specific design elements to prespecify in the protocol (i.e., before conducting an externally controlled trial) include suitable study data sources, baseline eligibility (inclusion and exclusion) criteria, appropriate exposure definitions and windows, well-defined and clinically meaningful endpoints, cogent analytic plans, and approaches to minimize missing data and sources of bias."
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