Post by
floatinketucky on Feb 28, 2022 12:04pm
4TLTFF Study II Status:
Theralase® has enrolled and treated 30 patients in a Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study ("Study II") (including three patients from the Phase Ib NMIBC clinical study (“Study”) treated at the Therapeutic Dose) for a total of 33 patients. Theralase® has completed its first significant milestone of Study II by enrolling and treating 20 to 25 patients, in support of a Food and Drug Administration (“FDA”) Break Through Designation ("BTD") Theralase® plans to compile progressive interim clinical data reports at various assessment dates (urine cytology and cystoscopy) for submission to the FDA in support of the grant of a BTD approval, when indicated.
Comment by
floatinketucky on Feb 28, 2022 12:06pm
The last patient updates were nov 29 2021... Data to date may be on the FDA review table now...