RE:RE:RE:RE:RE:RE:RE:RE:made the TOP TEN BULLBOARDS Again Skys1 ... Way before the arrival of Vera ... And It's not Vera that is driving this, it's the FDA rules and the data.
May 29, 2020
“In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data collected to date. 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.”
Nov. 15, 2021
Effective October 25, 2021, Dr. Vera Madzarevic, Ph.D. will assume the role of Director of Clinical Development and Quality Assurance reporting to Dr. Mandel.