NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

might want ti take particular note:

The use of external control arms in oncology is an evolving area of methodological advancement and regulatory interest. Thus far, external control data have been limited to establishing natural history or providing supportive data analyses affording clinical context for an observed treatment effect. These data have not provided pivotal support as substantial evidence of treatment effectiveness in oncology, and therefore have not yet been included in the prescription drug labeling. In the future, it is possible that formal analyses for comparative treatment effect between an investigational therapy and an external control arm would provide the primary evidence of efficacy to support a regulatory approval in oncology, particularly for a disease type with a highly predictable natural history and the precisely measurable treatment effect. LOL LOL