RE:RE:BTD Fast Track Designation (“FTD”) was granted by the US Food and Drug Administration (“FDA”) to Theralase® in November 2020. In order to potentially qualify for Breakthrough Therapy Designation (“BTD”) the Company has been advised by the FDA, to provide clinical assessment data for the primary, secondary and tertiary objective for approximately 20-25 patients treated at the therapeutic dose level.
This is from website and is what I am referring to