Theralase Technologies Inc. V.TLT

Alternate Symbol(s): V.TLT.W | 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. > Confirmation...

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Comment by baystock1on Aug 17, 2020 4:28pm

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Post# 31419686

RE:Confirmation...

Yajne wrote:

That an FTA application has been formally submitted, also the actual date of that submission was not provided. They must feel that results were 'good enough' to make an attempt for FTA

"Based on this guidance, Theralase® has submitted an application to the FDA for FTA and is currently awaiting their response"

The below quote from the newsletter implies that the basis for the Fast Track Approval application is the phase 1b results:

In a 3Q2019 conference call with the FDA, it was discussed between the FDA and the Company, that the Company would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data collected to date in the Phase Ib NMIBC clinical study.