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. > INVESTORS ARENT BUYING IT YET

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Comment by Eoganachton Aug 25, 2024 4:32pm

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Post# 36195353

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:INVESTORS ARENT BUYING IT YET

Hi CancerSlayer - I completely agree that the way DOR is reported gives a false picture of a treatment's efficacy and "a high percentage of a low percentage is still a low percentage."

However this is the way all of the competition reports their data and the FDA is used to receiving data this way and they rule on treatment approvals citing this sort of DOR presentation as one of the criteria for their decision.

For years now posters here have been contributing alarmist posts to this forum, lamenting how this treatment or that treatment has completely defeated Ruvidar PDT in terms of efficacy. But it almost always turns out that they are comparing the deceptive DOR rate, based on a population of "responding patients only" with Theralase's absolute CR rate, based on the population of all evaluated patients. I and a few other posters here have explained over and over again (with limited success) the trick that was being played to make it seem like the competing treatment has as good or better efficacy than Ruvidar PDT.

Up to now Theralase has doggedly stuck with it's straightforward presentaion of the CR rate - ie - the percentage of patients with a CR out of the total population of patients evaluated at a certain point in time (including NR patients who would have been evaluated at that point in time if they were still in the trial).

But enough is enough!

Our competitors are not going to stop reporting their data this way and the FDA is not going to insist that they do.

Theralase cannot afford to be the only honest actor in the field and risk appearing less efficacious than inferior competing treatments.

So, as of the last news release, Theralase has begun reporting DOR data like everybody else.

By the way I continue to have a quibble with your 12 month CR rate for Ruvidar.

You have:

Ruvidar 12 month CR rate = 28% (18/65)

I believe it should be:

Ruvidar 12 month CR rate = 31% (18/59)

CancerSlayer wrote:
Per FDA guidance (August 2024, Revision I), the primary efficacy endpoint for bcg-unresponsive NMIBC with CIS should be CR rate. Sponsors should consider CR rate in the context of the duration of CR.

Keytruda CR rate = 41% (39/96)
Keytruda 12 month CR rate = 19% (18/96)

Ruvidar CR rate = 63% (41/65)
Ruvidar 12 month CR rate = 28% (18/65)

The goalposts set by Keytruda lie a short distance away...an extra point should win this contest imo.

Note: Imo, it's intellectually dishonest by the FDA to report/view a DOR rate using "responding patients only". This can give a false picture of a drug's true efficacy at a given point in time. This artifical enhancement of an otherwise low CR rate deserves a bid farewell...a high percentage of a low percentage is still a low percentage. JMO...