RE:RE:RE:RE:Fast Track StatusHempdoc wrote: Quattro74 wrote: Maybe they left it up to the patient? Here is your choice sir/maam, we strap you in, put you out and use this older solidstate tech over half a day. Or you wait a few weeks for reb approval and we can use this new, comfortable, flexible tech with a local anesthetic, and you're out in two hours???
Macer wrote:
Eoganacht 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
I don’t think they would enroll a patient to give that patient a choice to wait an undetermined amount of time IMO...too much risk to the patient & such a wait has the real potential to negatively impact the data.
Shawn mentioned at the AGM that there a 6 week period between TURBT procedure and TLD 1433 treatment. I was left wondering if this is the norm or simply the planned to timing related to the study and new laser. Kipton did show off the new laser and was quite impressed with its innovations. I still feel it is a mute point. Can’t get better than a 100% CR. And improving safety is of minimal concern because it’s already safe, optimize but don’t delay the trial
macer