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. > Crutial 450 day data.

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Comment by wildbird1on Nov 14, 2022 6:58am

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Post# 35095870

RE:Crutial 450 day data.

greaterfoolfred said, Wildbird you can not use the 4 undertreated patients (3CR+1NR) in your post.

Ok, let's get rid of the 4 undertreated patients in my post.

25 patients - 4 undertreated = 21 patients left(which is in the rage of the 20-25 patients required by the FDA).
15CR/21 patients = 72%CR.

Even better let's replace in my post these 4 undertreated patients(3CR+1NR) by 4NR patients for a total of 25 patients.
We have 15CR patients/25 patients= 60%CR.
Considering that these patients were 100% guaranteed to lose their bladder, 60% CR is huge.
Doesn't matter how you look at it, the numbers are great.

wildbird1 wrote: The 18 optimized patients 450 day data are crutial for the BTD application in Dec 22. Let's see why.

First what we know.
-In Dec 22, 18 optimized patients will have completed their 450 day data.
-In Dec 22, TLT will submit data on 20-25 patients for BTD application.
-The treatment protocol that has been approved by the FDA, is the "Optimized Treatment Protocol".
- With the "Optimized Treatment Protocol" approved by the FDA, we can easily assume that the 18 optimized patients 450 day data will be the first data that will be included in the 20-25 patients data that TLT will submit to the FDA for BTD approval.
-From the 1Q2021 Newsletter, we know that once a patients has obtained a CR(Complete Response), the duration of the response remain fairly durable(Approximately the same at 180,270,360 day...etc).

1) 18 Optimized patients CR%.
From the 3Q2021 Newsletter, we know that the 90 day CR% on 11 optimized patients(18-7 pending=11 patients) is 8CR/11patients=73% CR.
Let's extrapolate for 18 optimized patients, 18x73%=13 CR patients/18 patients.

2) From the 3 patients in the Phase 1b Study...(included by TLT in the phase 11 study data) we have 2CR patients.

3) From the 12 undertreated patients we have 3CR patients(25%).

Remember once a patients get a CR, the duration of the response remain fairly the same.
Dec 22, 20-25 patients CR%.
The 20-25 patients data that will be submited to the FDA in Dec 22,could be as follow.
13 CR patients(from the 18 optimized).
+5 remaining patients (from the 18 optimized).
+2 CR patients (from the Phase1b study).
+1NR patient (from the Phase 1b study).
+3 CR patients (from the 12 undertreated).
+1 NR patients (from the 12 undertreated).
Grand total 25 patients.
18 CR patients/ 25 patients= 73%CR in Dec 22.

All the above could explain why Dr.Arkady Mandel, in a June 24,2022 PressRelease said " The success in the Phase 1b NMIBC clinical study, has led to the impressive preliminary results demonstrated in the Phase 11 NMIBC clinical study".

Note: Dr.Mandel gave us a big clue when he said " has led to" indicating that these impressive preliminary results are genuine, and only need to be compiled and certified in Dec 22.

Dec 22.
Very soon.