RE:RE:RE:BTD Approval Request...???I don't know that the timeline to BTD is that far away. The wording that was used suggested that an interim analysis could be done when 20 were successfully treated. Is that interim on the way to 100 patients or interim of the 360 CR timeline? Safety is still very hi and efficacy seems to be even higher when you look at optimized. The risk is low since it's safe. These patients are looking at bladder removal. There appears to be no risk, only gain. This should get BTD now.
It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated.”