Enjoy the holidays and dream nice dreams !Remember Theralase has already received Fast Track Designation for TLD-1433, which indicates the FDA's recognition of the drug's potential to address an unmet medical need
Theralase Granted FDA Fast Track Designation for NMIBC Phase II Clinical Study – Theralase Technologies
and the likelihood of TLD-1433 receiving FDA Breakthrough Therapy Designation (BTD) is promising, given the positive interim results from the Phase II clinical trial. For the primary endpoint of Study II (CR at any point in time) 61.9% (39/63) [42.5, 81.3] of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR (negative cystoscopy and negative urine cytology; positive cystoscopy (low grade) and negative cytology or negative cystoscopy and suspicious / positive urine cytology with confirmed upper tract / prostatic urethra disease and negative bladder biopsies). Including patients, who demonstrated an IR (negative cystoscopy and positive or suspicious urine cytology), the TR increases to 68.3% (43/63) [47.9, 88.7].
This represents that greater than 2 out of 3 BCG-Unresponsive NMIBC CIS patients treated with Theralase®'s unique Study Procedure are demonstrating complete destruction of the cancer in their bladder.
2024-11-27 | Theralase(R) Release's 3Q2024 Financial Statements | TSXV:TLT | Press Release
TFSA Room Availability days away :-)