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andy55q

09/01/16 8:16 AM

#13619 RE: powderbum #13617

Before that happens the balance sheet needs to be cleaned up,litagation settled,rights/ownership of technology needs to be clarified.

Bigspirit1

09/01/16 10:10 AM

#13620 RE: powderbum #13617

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

Bigspirit1

09/01/16 10:21 AM

#13621 RE: powderbum #13617

I agree that the clinical trial can be done, but it is not as easy as your post indicates.

Calmare has to be compared to sham. Sham results are sometimes as high as 30% but in the US in pain therapy, can reach as high as 40%. So think in terms of 50-60%. Add to this that the FDA likes trial results repeatable at different locations and the fact that Calmare results are user dependent and it is not as easy as you make out.

Doable? Absolutely, but it is not a walk in the park.