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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 CancerSlayeron Jan 27, 2023 12:42am
270 Views
Post# 35249489

RE:RE:FDA Approval for TLD1433 pdt almost certain IMHO

RE:RE:FDA Approval for TLD1433 pdt almost certain IMHO

Kingpin68 wrote: Eog, what do you make of the wording here : 'Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.'
Why ' high grade recurrence '. Is low grade recurrence acceptable. And how does that compare to TLD's partial response numbers. Isn't a partial response the same or similar to being free of high-grade reoccurrence?
 

 

To put it simply, low-grade recurrence is acceptable per FDA guidance.  A partial response reflects either a low-grade cancer within the bladder or it simply represents a "yet to be determined" status wherein confirmation of cancer existing outside of the bladder is still pending.

More technically, a PR is defined as a patient who either displays a positive cystoscopy & negative urine cytology or a negative cytoscopy & positive urine cytology.  A positive cytoscopy can represent either low-grade or high-grade NMIBC.  In a patient that has a negative urine cytology & a low-grade form of NMIBC is detected (meets PR criteria), such a patient can be re-classified as a CR.  A patient with a negative cytoscopy but positive urine cytology can also be reclassified as a CR when it is confirmed by CT or other method that there is also cancer present in either the upper or lower urinary tract (i.e. ureter/kidney or prostatic urethra, respectively).  Good luck...

 

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