BTD and / or AAIt 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.”