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. > « interim analysis » and « successfully treated »

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Comment by wildbird1on Mar 17, 2022 10:26am

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Post# 34521684

RE:RE:RE:RE:RE:« interim analysis » and « successfully treated »

ScienceFirst ...
The highlighted line in your post seem to indicate that once BTD(Breakthrough Designation) is acheived, the AA (Accelerated Approval) process goes very fast.

The accelerator seem to be BTD.
TLT is closer than ever to BTD.

Good time are coming.

ScienceFirst wrote: Intereting link WildBird1. Worth giving it more visibility.

Fig. 1 (unreproducible here because of SH pathetic outdated technology) is of interest.

https://pubmed.ncbi.nlm.nih.gov/28420989/

. 2017 Apr 3;8:161.
doi: 10.3389/fphar.2017.00161. eCollection 2017.

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

Abstract

The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a "metro map" to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs. For these 74, development times ranged from 1,458 (BTD + PR + AA) to 3,515 days (PR). PR alone had a median approval time of 242 days. The most common combination was FT + PR (median approval 292 days, n = 21). The fastest approval times were for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days). Our findings support the combination of FRPs for shortening development and review times beyond that provided by PR alone.

Keywords: Accelerated Approval; Breakthrough Therapy; FDA; Fast Track; Priority Review; facilitated regulatory pathway; review times.