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. > Possible Approval Timeline

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Comment by Eoganachton Nov 26, 2020 8:36pm

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Post# 31986409

RE:RE:Possible Approval Timeline

Hopefully that will be enough. But we may do much better than that.

enriquesuave wrote:
I have noticed that they did not mention a specific number percentage of CR for Accelerated approval. Just says " significant safety and efficacy clinical outcomes " perhaps the FDA is up to speed on the under treatment of the first 12, and if the next 13 show significant efficacy then Accelerated approval is in the bag. So maybe if 67% or better is achieved in next batch of patients,that may be enough? Who know we shall see.

Eoganacht wrote: From the news release:

FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.

If Theralase can apply for accelerated approval with one year results for 20 to 25 patients, priority review would mean approval within 6 months of the FDA receiving the application (shaving 4 months off regular review)

It's possible FDA approval may come around 1.5 years after the treatment of patient 25.