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.

TSXV:TLT - Post by User

Theralase Technologies Inc. > The FDA might have no choice...

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Comment by Eoganachton Mar 19, 2022 5:16pm

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Post# 34528766

RE:The FDA might have no choice...

Hi wildbird1 - the competition is not doing nearly as well as you wrote in your post. I think TLD1433 will have a far higher CR rate than either Keytruda or Immunobio's drug. And as you have noted TLD1433 has a far better safety profile than Keytruda and requires far fewer treatments than either of them. I wrote some comments below in red.

wildbird1 wrote:
The FDA will give TLT treatment BTD(Breakthrough Designation) & AA (Accelerated Approval) only if the FDA see that there is a pressing need for TLT treatment.

Lert's see how the competition is doing...

1) BCG...
BCG is the standard of care, unfortunately there is a shortage of BCG.
https://discover.vumc.org/2021/02/bcg-shortages/will-persist/
As we speak regular patients are placed on a waiting list for BCG treatments, during that time there cancer could be progressing.

BCG is not our competition, at least not yet. Our current NMIBC trial is for BCG-unresponsive NMIBC. It is the 40% of NMIBC patients who fail to respond to BCG that is our market. Later on TLD1433 may go head to head with BCG but not yet.

2) Keytruda...
Keytruda has a 41% CR at 12 months, unfortunately Keytruda has very bad side effects.
https://keytruda.com/side-effects/
(Quote) " Keytruda can cause your immune system to attack normal organs and sometimes become severe or life threatening and can lead to death".(End Of Quote)
Nothing more need to be said about Keytruda.

Keytruda did not achieve 41% CR at 12 months - it achieved 18.75% CR at 12 months. Altogether 39 of 96 patients achieved a CR in the study. 18 of those 39 patients were still CR after 12 months, that is, 41% of the 39 CR patients or 18.75% of of the 96 trial patients.

3) ImmunityBio...
ImmunityBio has a very good CR% of 71%/24 months(2022 numbers).
Unfortunately each patient need to start with 6 treatments in six weeks of BCG+N-803 and maintenence treatments of BCG+N-803 for up to 3 years.
That is a lot's of BCG treatment for just one patient.
Because of the shortage of BCG & the high number of BCG treatments needed for just one patient, the waiting list for the immunityBio patients could be very long, and by the time BCG become available the patient cancer could be progressing.

As above the 71% CR rate is for CR at any time in the trial. The CR rate at 24 months was around 42%

TLT treatment is a stand alone treatment.
The FDA might have no choice and see that TLT treatment doesn't need BCG, has no side effects and a CR% over 70%(could much higher for the optimised patients), all the above could be a very good reason for the FDA to give TLT treatment BTD & AA much faster than expected.