I could post in response the message I wrote that this post of yours responds to and just go around in circles with you but I think I’ll just let you enjoy the merry-go-round all by yourself with one little additional push for you to think about. FDA and the peer reviewers at JAMA are and were very well aware of the screening hold and that all the treatment arm patients were enrolled while 17 SOC/placebo patients were deliberately left out. There is a very good reason for that which is why guidance regarding real world data and real world evidence guidance was brought in and why JAMA supported this trial data by publishing it after thorough review. It’s called living patients with real beating hearts not just a KM projection that may not measure up with reality. Now take a spin with THAT for a while !; ). Best wishes.
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