NorthWest Biotherapeutics Inc (NWBO)

[DocLee]

Maverick, may I bring to your attention the excerpts below from a guidance document produced by the FDA in October 2022:

17th October 2022
Food & Drugs Administration
Tissue Agnostic Drug Development in Oncology
Guidance for Industry

This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. For the purposes of this guidance, the term “tissue agnostic oncology drug” refers to a drug that targets a specific molecular alteration(s) (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type. A tissue agnostic oncology drug can therefore be used to treat multiple types of cancer (eg colorectal, thyroid and breast cancers) with the targeted molecular alteration (eg, either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway). Although applications for a tissue agnostic oncology drug are reviewed for safety and effectiveness under the same legal and regulatory standard as drugs for a tissue specific cancer, the development of a tissue agnostic oncology drug raises issues that generally do not arise in the more traditional development approaches, this guidance describes the development pf tissue agnostic oncology drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such drug development.

and

A tissue agnostic oncology drug can therefore be used to treat multiple types of cancer (e.g., colorectal, thyroid, and breast cancers) with the targeted molecular alteration (e.g., either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway).

To me it seems that DCVax-L fulfills the criteria for being a "tissue agnostic oncology drug".