Speculation and opinion is not facts. The only way to know if the trial is positive or a failure is unblinding and analysis of the data. Now, that's a fact. Opinions are like A-holes, you and everyone else has one.....
FDA, DMC have a duty to stop the trial new and patients already enrolled if the futility/safety is a concern but this trial is going on for over 10 years. Do you think they are sleeping?? Or who is illiterate here??