NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Yes, the external control arms do not have patient level data

which is not required in the sense what exwan meant and what you justifiably said competing companies did not deliver to NWBO

During the submission process, researchers will need to show the patient-level data used to create their ECA along with the corresponding data from the investigational arm. The Clinical Data Interchange Standards Consortium’s (CDISC’s) Study Data Tabulation Model (SDTM) is typically used for data submitted to the regulatory agencies, but sponsors may wish to discuss other appropriate data standards and current requirements with the review division, if necessary.

NWBO did adhere to this requirement. So in other words there is a misunderstanding here of what patient-level data means. If we take the cotahealthcare article definition then NWBO DID meet that requirement.

https://cotahealthcare.com/building-a-better-eca-5-steps-for-submitting-an-eca-to-regulators/