NorthWest Biotherapeutics Inc (NWBO)

[beachhyena]

Thanks for the titbit Fireman.
So what we are looking at is the biomarker approach where DCVAX-L can be used across multiple cancers without the need of further trials.

From the guidance..

For the purpose 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 (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). Although applications for a tissue agnostic oncology drug are reviewed for safety and effectiveness under the same legal and regulatory standard as drugs indicated for a tissue specific cancer, the development of a tissue agnostic oncology drug raises issues that generally do not arise in more traditional development approaches. This guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development.