Or this?
"concurrent with an early halt for efficacy, if that should happen. It's rare, but if the treatment is showing very high effect with statistical significance, it would be deemed unethical to continue all the way to the end. Statistical significance with a trial powered such as this one could possibly be achieved this summer (60% events had occured in Dec). It's a real possibility.
Our discussion on AA was short. I showed you FDA guidance which stated a process by which a company would file an NDA or BLA for AA using an interim analysis as the basis, while the trial continues to satisfy the post AA confirmatory trial requirement. You, my friend, are the one who refuses to get it. FDA wants to see a confirmatory trial IN PROGRESS when granting AA. Why? So many of the companies granted AA drag their feet thus for many years, while taking full advantage of their newly acquired marketing capabilities. FDA is changing the way this works. It appears they are wont to demand a conf trial in progress before they consider AA. One way around this, is to use the interim data of a larger Ph III trial as the basis of AA, etc... :
"When it is possible to use a later effect in a trial to verify the effect seen earlier in the same trial that supported accelerated approval, the same clinical trial(s) can be used to support accelerated approval and verify and describe the clinical benefit. In this case, the protocol and the statistical analysis plan should clearly account for an analysis of the surrogate endpoint data to provide support for accelerated approval, with continuation of the randomized trial(s) to obtain data on the clinical endpoint that will be the basis for verifying the clinical benefit. When the same trial is used to support accelerated approval and verify clinical benefit, the data to verify the clinical benefit may be, in some cases, nearly complete by the time of accelerated approval."
