@fourdollars telling it like it is. Dodgy use of p-values is rife in medical trials and this particular study may have been called out by the COC for what it is. Once of my previous posts pointed to this issue of the signal and the noise. The COC could ne onto the fact that allowing a company to roll out a treatment where any outcome in the study may be entirely due to chance may well be irresponsible, and given the payload, potentially dangerous. Remember, this is a device, and dangerous implantable devices of all types (mesh, artificial joints, breast impants etc.) have a lot to answer for, especially in the EC. Yes, a ptentially life-saving device might be viewed differently, but not when it can't be proven against a control that the device actually made a difference.
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