RE:RE:RE:RE:sigh 2023
Central Pathology Laboratory Review - Use of a central pathology laboratory to validate local pathology laboratory resultsIn addition, Theralase® is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II Treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a pre-Break Through Designation ("BTD") submission."
2024 3. Reviewing and analyzing the existing clinical data to ensure accuracy.
4. Securing review ethics board approval and patient consent to obtain patient clinical data up to 3 years from date of primary Study Procedure
5. Providing training and support on central pathology analysis of urine cytology and bladder biopsy pathology samples.3. Reviewing and analyzing the existing clinical data to ensure accuracy.
4. Securing review ethics board approval and patient consent to obtain patient clinical data up to 3 years from date of primary Study Procedure
5. Providing training and support on central pathology analysis of urine cytology and bladder biopsy pathology samples.