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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 floatinketuckyon Jan 23, 2022 2:31pm
143 Views
Post# 34350189

RE:RE:RE:Q4 2020 newsletter was released Feb 1, 2021

RE:RE:RE:Q4 2020 newsletter was released Feb 1, 2021
99942Apophis wrote: floatinketucky wrote

So if they released on Feb 1st for q4 updates the qr update would inclued time from Nov 29th forward to Dec 31.   Right??

That would bring the Newsletter proper and current. 



Hi floatinketucky its only for the financial period for the 4th quarter or year end that they must stick to December 31. If they release the Newsletter same as last year for February 1st they can release data up until then, they probably will only have patients 25 & 26 hitting their 90 Day point as of February 1st and in the 180 Day perhaps only 1 patient achieving that goal. 
Because patient 25 is a strong point of interest being the number required for Breakthrough Designation (BTD) your opinion that Feb. 1st could be the date we see the Newsletter or even a news release because of material importance has a very good possibility of happening. 


Lets go with 20 to 25


Operational Highlights: 

  1. FDA Fast Track. On November 23, 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II.  As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with TLC-3200, to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with Bacillus Calmette-Guerin (“BCG”) – Unresponsive Non- Muscle Invasive Bladder Cancer (“NMIBC”) Carcinoma In-Situ (“CIS”), with or without papillary Ta or T1 tumors.  FTD can lead to an Accelerated Approval (“AA”), Break Through Designation (“BTD”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
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