IR chat 31 JanI talked with investor relations. FDA submission H1 and 120 day window for FDA to respond (new regulation for medical device approval process). Expect fall2018 FDA decision
FDA was actively involved in producing a sham/placebo arm but also recognized it might have some effect (which it did). FDA realized that was a possibility so it designed in the registration trial the allow the combining of the 2 arms. The combined arms showed clear benefit at p<0.05
Main company focus is on their production side, having partnered as per prior new release. Ongoing, trials (MS etc. ) represent very little cash burn. 1 to 1.5M monthly burn.
Expect equity raise mid year on the US side after they get approved for NASDAQ listing (he didn't object when I suggested that). Besides share price, getting independent directors, some financial requirements are all in process.