NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Bob_LobLaw,

Acceptance of new or newer methods by peer review is important for not only this BLA but for use of SAP methods going forward and establishing methods as standard practice. This is one of the probable reasons for no update on ClinicalTrials.gov regarding endpoints. Not that the endpoints and methods used to measure aren’t acceptable, rather they just have not been validated as acceptable until approval. Changes are often accepted and standardized by FDA only when a general acceptance has been noted in the larger clinical and academic settings. If you read enough of FDA literature you will find this to be true which is why Dave Innes might say this. Best wishes