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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 stocksnbonds458on Jan 17, 2024 11:32am
192 Views
Post# 35831320

RE:RE:RE:RE:BTD is slow process.

RE:RE:RE:RE:BTD is slow process. Agreed patience. From what I understand it's just a matter of retrieving information and data from the study sites that is already existing, they are not requesting new data to be extrapolated . The process of requesting this information is soooo textbook bureaucracy.

First they must:

1. Submit a request to the Study Coordinator at each Site to receive approval from the patients to allow the release of information. 

2. Once that is in place, they then must submit a request to the Coordinators for the data that the FDA has identified to TLT.

3. The Coordinators have to assemble this data and send it to TLT, where  then TLT will prepare and submit the updated Pre-BTD letter to the FDA.

TLT began this process in August, shortly after the request by the FDA for more information. As far as I know we are still somewhere in between variations of numbers 1, 2, and 3 above. Hopefully after pre-BTD is okayed, then they should be in a position to submit a formal BTD application. IMO, if the FDA approves the pre-BTD, then receiving the actual  BTD should be almost certain. In other words, if we get pre-BTD approval by May, then it's time to fire the rockets!!!
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