iclight,
That’s a completely false statement. FDA can not stop a trial for efficacy on their own. The company must agree. If stopping early hurts the company’s chances for approval because of things other than treatment effect or the company wants to gather longer term usable data to determine longer term treatment effect the trial is allowed to continue. The one thing that can not continue in Germany when a determination of positive effect is known, ie Fraunhofer’s statement, is subjecting a patient to a lesser known treatment. By the time of the hold longer term data was already available that would have demonstrated early treatment patients were doing better than late treatment patients at 5 years. Try again, I’m hungry; ). Best wishes.