RE: September has legs..... As far as your "don't be surprised by a "fast track" to approval from FDA", you are making assumptions that are a bit extreme, imo. Knowing what is happening in the trial is a bit presumptive on your part. The other "trials" did not have the parameters this Phase 3 trial has so to assume all will be the same is a bit far fetched.
Also, what is the purpose of an "interim analysis"?
Will you answer any of the questions posted?