NorthWest Biotherapeutics Inc (NWBO)

[iclight]

The SAP is a moot point because the trial design is bullshit.

This is from a huge law firm that assists companies with clinical trial issues.

King & Spalding

Consistent with FDA’s prior guidance on the use of RWD to develop RWE for regulatory decision-making5, the External Controls Draft Guidance clarifies that multiple sources of patient-level data could potentially serve as the control arm data in an externally controlled clinical trial, including but not limited to data from other clinical trials, registries, natural history studies, electronic health records (“EHR”), and medical claims data. The External Controls Draft Guidance emphasizes that summary-level data will not suffice for use in an externally controlled trial.

And here's confirmation that the trial is shitty when one actually reads the FDA document on external controls:

IV. CONSIDERATIONS TO SUPPORT REGULATORY REVIEW

Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations, 33 for both the treatment and external control arms. If sponsors do not own the data used for the external control arm, they should structure their agreements with the data owners to ensure that patient-level data can be provided to FDA in support of the marketing application.