NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

what does fda saY::

Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival. Apparent differences in outcome between external controls and current treatment groups can arise from differences other than drug treatment, including patient selection, improved imaging techniques, or improved supportive care. Randomized studies minimize the effect of these known and unknown differences by providing a direct outcome comparison. Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable and has often supported new drug approval.