Friday, December 17, 2021 1:55:00 PM
The data accrued to date for the TLD 1433-2 open label study for the treatment of NMIBC, seems very encouraging, and Theralase may as well be heading towards fulfilling the necessary outcome requirements to apply for a “BTD from the FDA very soon.
Dr. Vera Madzarevic Director Clinical Development & Quality Assurance, Theralase®
In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved a Partial Response (“PR”) are being further assessed via Computerized Tomography (“CT”) scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma (“UCC”) or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.
Effective October 25, 2021, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance in the biopharmaceutical and medical device industry to Theralase®.
https://theralase.com/wp-content/uploads/2021/11/3Q-2021-Newsletter.pdf
JMO, maybe, maybe not.
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