You guys constantly avoid the talk about the exceptions rule to adequate and well controlled trials because it throws a big monkey wrench into your post hoc arguments. Well too bad if you don’t want to include this in your narrative because it sheds light on the fact that using the exceptions rule in this case is precisely why it is in the guidance in the first place. Some methods thought to be sufficient to properly measure treatment effect simply fail to do so especially when novel treatments produce a different form of treatment effect such as delayed response or treatment related pseudoprogression. Feel free to state otherwise but deliberately leaving out the mention of this pathway and trying to impart a negative sentiment about it’s use when previous methods for measuring treatment effect have been known to be abysmal for such an extended period of time makes your claims about post hoc changes completely invalid. Those who take the time to study the exceptions rules can judge for themselves if your claims and those of others referring to post hoc changes are likely deception by omission or NWBO just following the guidance for when old measures are no longer sufficient to determine treatment effect accurately. Best wishes.
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