You are discussing why having a high N value is useful in a study where there is significant heterogeneity within the population and the disease.
You're absolutely right, but what that means is a properly designed trial is extremely important.
In no way is a single arm trial superior to an RCT. Again, not how science works.
I'm going to stop responding, honestly, because we are going in circles.
There will be ten more replies, all explaining why RCTs are no longer necessary, why it's cruel to do RCTs, why MSB shouldn't be held to the same standards as all other pharmaceutical researchers are held, etc.
Let's agree to disagree. Doesn't really matter, at the end of it. What matters is whether the FDA is convinced by the data, despite MSB not performing the study they recommended.
Then, if it's approved, whether there is compelling enough evidence for it to change clinical practice.
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