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longfellow95

01/26/20 1:22 PM

#261471 RE: AVII77 #261210

..demonstrates the importance of recognizing patient selection issues.



Which kind of makes the Optune results look really nothing special at all. They waited the longest of any comparable trial in order to exclude progressors, and allow entry to pseudo-progressors.

When you know you are control (no contraption to wear), you cannot even benefit from a placebo effect. Though the opposite does apply; the 'nocebo' effect, when outcomes are inferior precisely because you know you are not getting an intervention.

They demonstrated an advantage over an underperforming control.
Yet accelerated approval was very quickly forthcoming.

Nobody asked the question (certainly not the FDA) as to why they had such a high percentage of unconfirmed meth status subjects.