RE:Fast Track StatusEoganacht wrote: In the June 27 NR Shawn Shirazi wrote:
"We can now proceed with completing and filing an IND application with request for fast track designation, which pending approval, would allow the Company to expeditiously and effectively extend our clinical study into the US, to qualify and onboard clinical sites."
If we receive fast track status, accelerated approval becomes possible once we have demonstrated the achievement of an intermediate clinical endpoint, such as complete response in a specified number of patients after a specified period of time after the initial treatment.
This ia very feasible in my opinion.
As for the laser, don’t get me wrong. I am all for optimization. The company said for itself that they did not need to delay treatment in the study to wait for the REB approval.
Macer