NorthWest Biotherapeutics Inc (NWBO)

[QL300]

Synthetic control arms are formed by carefully selecting patients from historical clinical trials to match the demographic and disease characteristics of the patients treated with the new investigational product. They have great potential to enhance single arm trials and enable more efficient randomized clinical trials in indications where the standard of care therapy is impracticable or unacceptable to patients.


This is exactly what the JAMA article did. The information they do have is sufficient for approval. Why would you think Medicenna would have access to differ information from historical trials than NWBO. They don’t have individual charts is what LL was saying. You don’t need that for approval and Medicenna’s approval of the trial is proof.