Replies to post #596532 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

No, it wouldn't.

DCVax-L clearly does not fit under the FDA tissue agnostic 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.

DCVax-L does not target any specific molecular alternation.

Besides, the guidance, like others, specifically states that OS is compared to ECAs is not a valid endpoint.

The FDA has reasons for saying this.