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. > New FDA Proposed Guidance on AA

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Comment by enriquesuaveon Mar 29, 2023 1:07pm

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Post# 35367265

RE:RE:RE:RE:RE:RE:New FDA Proposed Guidance on AA

Th FDA didn't ask Adstiladrin for a RCT. Adstiladrin had received a CRL for manufacturing issues after they filed for BLA. We will only need an NDA. Chances of a CRL for an NDA based on manufacturing are basically nil, they will mainly look at efficacy. IMO

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