IPPS, page-14

With respect, I'm well aware of how to interpret clinical trial results, and suspect you don't know what a p value actually represents without looking it up, nor what other values are used in clinical trials. This study wasn't powered for significance. If they had an endless wad of cash they could have enrolled 500 patients in the study and it'd increase the power. But that'd mean 500 MRIs ($$). A quick look at the raw results will show you that even despite the small number in the study the results were almost certainly not due to chance. This was one smaller study of a number that the company has done to support the final application. So they save the money for the larger trials, which have to date shown statistical significance for the endpoints.