Replies to post #706001 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

NWBO did however not meet the patient-level data requirements as made up by you and ex.

is littery what I said. the individual patient-level data for the ECPs is NOT AN FDA REQUIREMENT

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

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.

a requirement NWBO did meet