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.

TSXV:TLT - Post by User

Theralase Technologies Inc. > Keep patient, maybe we are at last step to the final victory

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Comment by Eoganachton May 15, 2024 8:38pm

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Post# 36042384

RE:RE:RE:RE:RE:RE:RE:RE:Keep patient, maybe we are at last step to the final victory

Theralase did not submit a BTD application in July 2023. What they submitted was a "Preliminary Breakthrough Therapy Designation Advice Request" after filling out a template supplied by the FDA.

"This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review division will make a recommendation as to whether a request for a BTD is appropriate, may be too preliminary, or does not currently meet the criteria for a BTD. The Agency’s recommendation is advisory and is not to be interpreted to predict the Agency’s decision on the BTD request."

TriumphSpitSix wrote:
Interesting theory.

Do we have evidence they also self-imposed a management blackout when they originally submitted BTD application in July 2023?

Two PPs closed around that time:

June 30, 2023
Sept. 7, 2023

Did RDW or other Director/Manager participate in those?