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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 DJDawgon Sep 23, 2024 8:53am
222 Views
Post# 36236061

RE:Hopefully

RE:Hopefully
My reading of the FDA website suggests that pre-BTD is a process where you run your application by a designated reviewer who tells you whether likely to fly or not. So not a complex thing but rather a short way of the FDA saving yours and their time by telling you to proceed with BTD or not. TLT has always called this pre-BTD and no one else does that I can tell. I assume that there is enough communcation within FDA that that pre-BTD and BTD reviewers are aware of what each other are doing and if the the pre-BTD person comes back with comments such as (example only) "strong application but would benefit from central lab and post 450 day data" then you have to take the hint that they are saying that you may get BTD but it is more likely if you come back with these things.

So my guess is that pre-BTD would be quick if they did it last year already and are just circling back with, "yes the central lab data confirms things" and "post 450 data looks good", what do you think about BTD now. The pre-BTD reviewer would then direct them on readiness for the formal BTD application which has a max 60 day turnaround.
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