Post by
floatinketucky on Feb 25, 2022 10:05am
based on the clinical study data collected to date
The Corporate presentation is of no interest to the FDA. The Company newsletter is of no interest to the FDA. The FDA is interested in the data to date. May 19, 2020Shawn Shirazi, "In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, 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 study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated." Currently the public only has information on this study up to NOV 28 2021.
Comment by
Gooseybear on Feb 25, 2022 10:07am
Agreed 109% float. With the past management missteps, TLTF will only be believed based on 100% verified data.