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. > Is this the year?

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Comment by Yajneon Jun 11, 2021 2:34pm

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Post# 33373406

RE:RE:RE:RE:Is this the year?

I'm having trouble reconciling Shawn's wording in the NR with the longer timing you're suggesting Eogan. His words could easily be interpreted to mean that they will submit data on the first 25 to the FDA shortly after treating twenty five patients, maybe at 90 days post treatment.

“It is exciting to see Theralase® clear another hurdle by treating the first patient in the US and move one step closer to achieving its next milestone of enrolling and treating twenty-five patients in early 2021. Once completed, Theralase® plans to submit the clinical assessment data on the first twenty-five patients treated in Study II to the FDA for consideration of Break Through Designation (“BTD”) status.”

Eoganacht wrote: An FDA standard review takes 10 months but Theralase has FTD which makes it eligible for priority review, the goal of which is for the FDA to take action on an application within 6 months.

chry200030 wrote:
FDA response takes 6 months? Meanwhile patients are dying !!!! Doesn't make sense...!!!