NorthWest Biotherapeutics Inc (NWBO)

[VuBru]

Well, their apparently revised SAP is certainly nontraditional, but it seems entirely consistent with what has been posted about recent FDA guidance on analyzing crossover trials in this type of orphan context. Maybe the critics are just locked into old thinking. I have no idea what the FDA response might have been to what they proposed, but doubt the company would proceed with DL and an analysis using the new SAP unless the FDA had at least said "well that might work given the confounded trial you have for this orphan condition." Ignoring FDA advice would simply be incompetent, and I cannot imagine the SAB would go along with that.