Hi Senti,
I do not know about the Fife part, but your view on the likely approach on the trial’s synthetic placebo arm is consistent with what I think would make the most sense from a regulator’s perspective. I can’t claim I know, but I do not think the back of the envelope, down and dirty comparisons between specific trials makes sense. A larger placebo group, reflecting similarities in actual treatment and outcomes seems more likely to be the best option statistically.
Some may obviously disagree, which is fine. But I think that is, in the long-run, where we are headed as they start to focus on data.