Replies to post #706005 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

You dont know the difference between

individual patient-level data

and patient-level data used to create their ECA along with the corresponding data from the investigational arm such as the Clinical Data Interchange Standards Consortium’s (CDISC’s) Study Data Tabulation Model (SDTM) is typically used for data submitted to the regulatory agencies

Since you are that clueless stop commenting on biotech

[dennisdave]

Consistent with FDA’s prior guidance on the use of RWD to develop RWE for regulatory decision-making5, the External Controls Draft Guidance clarifies that multiple sources of patient-level data could potentially serve as the control arm data in an externally controlled clinical trial, including but not limited to data from other clinical trials, registries, natural history studies, electronic health records (“EHR”), and medical claims data.

Game over for you.
https://www.kslaw.com/news-and-insights/fda-issues-draft-guidance-on-external-controls-in-clinical-trials-to-support-safety-and-efficacy-of-a-drug

Funny how you keep refusing to provide any source what you keep claiming