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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 enriquesuaveon Nov 01, 2024 4:52pm
197 Views
Post# 36293023

RE:Preliminary Breakthrough Therapy Designation (BTD) Advice

RE:Preliminary Breakthrough Therapy Designation (BTD) Advice

Basically it seems that if the FDA gives a thumbs up for BTD application, then it's a good sign but no guarantees.  If they don't agree, then you can still file BTD, but good luck.  I think we should fall in the first category.  


Eoganacht wrote: The FDA BTD FAQ site makes it clear that preliminary BTD advice is advisory and does not predict the actual BTD decision.

Frequently Asked Questions: Breakthrough Therapies


Question 22. What are the timelines for FDA to respond to a breakthrough therapy designation request? 
 
FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request. 

Question 23. Can a sponsor get preliminary breakthrough therapy designation (BTD) advice from the review division prior to the submission of a formal BTD request?
 
A sponsor can contact the regulatory project manager (RPM) in the division to which the active IND is assigned and request the “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template. This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review division will make a recommendation as to whether a request for a BTD is appropriate, may be too preliminary, or does not currently meet the criteria for a BTD. The Agency’s recommendation is advisory and is not to be interpreted to predict the Agency’s decision on the BTD request. NOTE: A Preliminary BTD Advice Request may be submitted to an active PIND, although a formal BTD request may not be submitted until the IND is opened.

 

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