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Theralase Technologies Inc. V.TLT

Alternate Symbol(s):  TLTFF

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.


TSXV:TLT - Post by User

Comment by tdon1229on Dec 13, 2024 6:11pm
262 Views
Post# 36361926

RE:RE:RE:Once pre-BTD was submitted

RE:RE:RE:Once pre-BTD was submitted When Study II was being set up (back before the pandemic and shutdown), it was explained that only a Phase II trial would be required.  However, if successful, then in lieu of the Phase III trial, Theralase would be required to keep a registry of all patients up through 300 in order to verify that the initial results from Study II are being maintained as the drug goes into general use.
This requirement resulted from the large number of recalled drugs in the period 2016-2022 when 18 of 35 approved drugs had to be recalled when general use results of those drugs failed to show the same efficacy and/or safety as were shown in the clinical trials.
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