NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Fudster HyGro has no idea about the ECA guidance of the FDA

Try actually reading the guidance, it is mot hard.

Reducing the potential for bias in externally controlled trials is best addressed in the design phase, in that well-chosen design elements increase confidence in the interpretability of study results when appropriate analytic methods are applied to estimate treatment effects. 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 lcontrol 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,18 baseline eligibility (inclusion and exclusion) criteria,19 appropriate exposure definitions and windows, well-defined and clinically meaningful endpoints, cogent analytic plans, and approaches to minimize missing data and sources of bias

Sponsors should consult with the relevant FDA review division early in a drug development program about whether it is reasonable to conduct an externally controlled trial instead of a randomized controlled tria

This guidance does not address other types of external controls, such as using summary-level estimates instead of patient-level data.

Plenty more from the FDA ECA Guidance that call BS on the NWBO post hoc crap.

But I am sure you will call this all just bluebook example of how the actual real world disagrees with your crap posts.