I really think you are over-stating the importance of the...

I really think you are over-stating the importance of the mid-term results to influence.

The hypothesis being tested would be that neurofeedback can positively impact an autism sufferer. In other words a patient would be making assumptions that if they are in the active group, they would be expecting improvement. Placebo safeguards against the patient willing themselves into improvement by the simple belief that this headband will make them better.

I don't really see the mid-term results changing that equation. The assumption was always that the treatment works. I don't expect this to impact the FDA submission at all