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. > Once the sites are open there is a screening period-28 days.

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Comment by Eoganachton Mar 28, 2021 12:07am

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Post# 32894209

RE:RE:RE:Once the sites are open there is a screening period-28 days.

"Shawn Shirazi went on to say, “In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase 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. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated.”"

- May 19 2020 news release

CancerSlayer wrote:
Floatinketucky wrote:
Also.... One more thing... Keep in mind the company has acess to the FDA for communication. And Shawn the CEO is about as reserved on predictions as anyone I have seen. So when he repeatly says we now need 9 for the 25 patient Breakthrough status expect that he know what he is talking about!

I agree that 9 more (at most) could get us to a BTD. Fortunately, the threshold for granting a BTD is more about promise & is less stringent than that for an accelerated approval. Considering the strength of TLT's science, that "25 patient" FDA guidance shouldn't have to change despite the previous removal of patients. I am hopeful the CR should be sufficiently promising even if the removed patients are included in the BTD decision-making by the FDA. I suspect the FDA could also base their BTD decision strictly on the 20 patients who were appropriately not removed, or simply await treatment of an additional 5, replacing those who were removed. There are other patient iterations, but I should refocus ; )

As for an accelerated approval (AA) decision, more strict statistical guidelines are obviously followed by the FDA. As opposed to a BTD decision, an AA decision is certainly based on more than just promise....JMO. Good luck...