RE:News Release InterpretationIt was implied (but not clearly stated) in the presentation of the registrational trial that the FDA was involved in how to design a sham device that could hide from the participants whether their device was active or not.
The way to handle the statistics of the so-called sham device (LFP) group, namely combining it's results with the active (HFP) group, if a P<0.05 was not achieved, may have had informal FDA input as well.
These are conjectures which I have asked IR about but with no response. I suspect that Helius would be loath to elaborate on the degree of FDA input in the study design as it could complicate the relationship Helius has with the FDA. Nonetheless, FDA involvement must be common in many study design approvals to avoid wasting time and money on a reviewing a poorly designed study.
Does anyone have more colour on this aspect?
I added shares on the post-presentation dip as I believe the study clearly shows an improvement that far exceeds that of physical therapy alone.