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Theralase Technologies Inc. V.TLT

Alternate Symbol(s):  TLTFF

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

Comment by CancerSlayeron Apr 14, 2023 12:56am
181 Views
Post# 35394538

RE:RE:RE:RE:Keytruda = $265,000 (17 doses per year)

RE:RE:RE:RE:Keytruda = $265,000 (17 doses per year)

N0taP00p wrote: Slayer, what are your thoughts on the smaller sample size with Theralase? Obviously, the FDA gave the green light for phase 1b completion with a very small sample size and then said 20-25 with similar efficacy and safety is good enough for BTD. These other ones you referenced above had higher sample sizes, correct?  Thoughts appreciated. 

 

Re: sample sizes required for BTD, I don't think our 20-25 patient threshold is an unusually low number, especially when you consider it involves a highly unmet indication.  Re: other referenced drugs, I have not followed the precise patient numbers that were required for a given accelerated pathway....perhaps others can chime in on this.  But historically, investigational drugs for high-unmet need cancers have not uncommonly been granted BTDs based on even less data &/or based solely on promising Ph 1 results.  

To date, our Ph 2 efficacy rate has not reproduced our Ph 1 rate; however, one should not worry as the updated guidelines in 2018 had set a significantly lower efficacy bar when compared to our Ph 1 results.  Experts continue to move the bar substantially lower based on the lack of patient-friendly treatment options & the lackluster historical efficacy rates of the currently approved drugs...as noted in my earlier post.  

Imo, a high 20s-low 30s durable response rate is well within our reach, & ultimately, any response rate that exceeds the relatively low bar set by the competition (low 20s) should receive an AA.  All imo.

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