NorthWest Biotherapeutics Inc (NWBO)

[foxhound02]

The paper would never discuss whether or not FDA accepts historical controls. Neither would the editor of the journal. There argument for external controls will be based on the difficulty with following a traditional approach given the design difficulties. That is what they will talk about. They will certainly cite other studies that used external controls. But the key point is that how FDA views this particular study is irrelevant.