Powderbum,
I agree that they need funding for the clinical trial. While I also agree that it is doable, I must tell you that is more difficult than you describe.
The proper way to run the trial is sham controlled. The placebo effect is generally around 30%, but in the US in the area of pain it can reach as high as 40%. So think of the needs for proof at 50-60%. Yes Calmare can achieve, but remember Calmare results are operator defendant. Add in the fact that the FDA prefers repeatable trials at multiple locations and the issues increase.
Doable...Absolutely. Not a walk in the park