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. > Phase11 450 days CR% data for BTD approval in Dec 2022...

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Comment by Rumpl3StiltSkinon Sep 05, 2022 2:21pm

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Post# 34942407

RE:RE:RE:RE:Phase11 450 days CR% data for BTD approval in Dec 2022...

Eoganacht wrote: It has probably crossed the minds of most posters, at some point, that instead of submitting complete data for patients 1- 25 to the FDA it might be better to submit the data of patients 13-37 and ask the FDA to remove the results of the first 12 patients as outside trial parameters. This would likely delay our preliminary data submission by a year, but at least the data would reflect the true efficacy of the treatment. But this, of course, is not going to happen. The data of the first 25 will be submitted as planned and we will have to rely on the good numbers of the next 100 patients to dilute the effect of the results of the 12 undertreated. Even if the FDA allowed the removal of the first 12 results they have already done their damage in the perception of the early efficacy results of the treatment.

CancerSlayer wrote:

Legit62 wrote: Wildbird, everyone keeps bringing up phase 1 results, the FDA will sure know how to look past non optimized patients when they review results, our results are very very solid at this point and should be even better next media release, share price wlll follow up, to what degree, i have no idea

Agree Legit....I have a very hard time believing the FDA would accept any invalid (or at least less valid) data from ANY trial that could ultimately compromise its final decision re: the grant of an AA, or even a BTD for that matter. Although data from the underdosed 12 may not impact our ability to get a BTD numbers wise, the final analysis & publication of trial results should NOT include this data set if scientific integrity still means anything.

My decision to invest my hard-earned money here certainly wasn't based on the possibility of quasi-scientific analysis. For the sake of sanity, general well-being & good science, we should put the under treated data set finally to rest...never to be discussed again (wishful thinking maybe ;). It functionally serves nothing more than to provide us a separate unintended cohort of patients that has no bearing whatsoever on our current ACT as recommended. All IMHO.