NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

This board thinks every document ever produced had DCVax in mind.

So true.

The FDA Tissue Agnostic Guidance sates clearly:

For the purpose of this guidance, the term tissue agnostic oncology drug refers to a drug that targets a specific molecular alteration(s)3 (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type.

Specific and "all antigens" are about as different as one can get.

Similarly Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

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

Actually worse though, as t also describes many of the issues with the -L trial.

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

Before initiating is not the same as before datalock.

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 for both the treatment and external control arms

NWBO does not have the patient level data on the ECA. It matters, that is why the FDA says "must include" it.

Plenty more.