No CEO knows the future, they can only take what their trusted vendors and employees tell them and pass that info along. If the FDA come to them and says everything looks great, but can we add this one thing, then the timeline changes. Is that the CEO's fault? Is it the vendors and employees fault? Is it not smart to hold people to timelines when you should know the future is full of changes?

Days on a calendar are not as important as progress in the right direction, which is what we have. Do you really think that Nader just makes this up and ignores the information as it is presented to him? do you think he should be explaining to investors that the FDA is a Kafka like bureaucracy that does unexplained things?

Big Pharma companies face the same hurdles, they are just less significant because they don't share the details of every step in the process unless they have to.