No, it's not troublesome or disconcerting. It just means the sample size was too small. Some ActiPatch studies fail and some succeed, but they are all underpowered. Yes, the FDA cleared the device based on three select studies, but being FDA cleared does not guarantee insurance coverage and it does not guarantee revenues.
And that's the reason why Pulsed Radiofrequency, including RecoveryRx, is not currently covered by insurance companies or Medicare: they all consider PEMF to still be in the investigational stage because the studies were underpowered. Example:
Aetna considers pulsed radiofrequency experimental and investigational for all indications, including those in the following list, because its effectiveness has not been established:
BIEL the company has no obligation to disclose Ilfeld's study results to anyone. For one thing, it's already publicly disclosed, easily found through simple DD. For another thing, BIEL the company didn't conduct this clinical study -- Ilfeld is an independent researcher.
Regarding the question "what is their backup plan for benefitting from the NOPAIN Act?" Call the CEO and ask. She often says that she wants investors to call her with questions.
And yes, those results are true, and yes, the trial is done. Again, this is all public information. I provided the link in the previous post but we've all seen it. I just hadn't looked at the pain VAS part yet since that has no bearing on the NOPAIN Act.
Personally, I don't think the NOPAIN Act will result in significant revenues for the manufacturers of the reimbursed drugs and devices. The Bill has other provisions that might help curb opioid addiction but the CMS reimbursement piece of the NOPAIN Act is a political stunt, IMO.
Whatever. Enjoy the rally! Maybe some of you managed to sell at .0004? Congratulations!