Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > Has TLT applied for BTD or not?

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Comment by Eoganachton Sep 07, 2023 11:36am

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Post# 35624155

RE:Has TLT applied for BTD or not?

"The Company has submitted a pre-BTD submission to the FDA and based on the FDA’s feedback, the Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in late 3Q2023 / early 4Q2023 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval in 4Q2023."