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Destroying Cancer at the Speed of Light®

Clinical Study Underway (75 of 100 Patients Treated)
Expected to complete enrollment at the end of 2024
Expected to complete study at the end of 2026


Bullboard - Investor Discussion Forum 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... see more

TSXV:TLT - Post Discussion

Theralase Technologies Inc. > Accelerated Approval
View:
Post by ScienceFirst on Mar 12, 2021 7:18am

Accelerated Approval

Nice catch EnriqueSuave.  Thanks for sharing.

Theralase is not on the list of that meeting but we can track when these meetings are being held in the future.

All those mentioned in your link have indeed published are news release:


Example:

March 8 - Roche - Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer


But remember the goofy Bunge with his famous pathetic "Hurry up boys!" thinking that Keytruda was a threat (while it was the complete opposite)while looking, I found this that shows Keytruda is failing in lung cancer.

By chance, TLT didn't cut corners just to satisfy Bungee's insatiable need for a share price just for a share price as opposed to a clear focus on clinical results and what it takes to bring us much further in terms of valuation thanks to a dominance as the next reference in NMIBC, NSCLC, GBM.

Merck withdraws Keytruda for lung cancer amid FDA crackdown (clinicaltrialsarena.com)

Continued approval for this indication was contingent upon completion of the post-marketing requirement establishing superiority of KEYTRUDA as determined by overall survival (OS). As announced in Jan. 2020, KEYNOTE-604, the confirmatory Phase 3 trial for this indication, met one of its dual primary endpoints of progression-free survival but did not reach statistical significance for the other primary endpoint of OS.

Merck’s consultation with the FDA on this withdrawal is part of an industry-wide evaluation of indications based on accelerated approvals that have not yet met their post-marketing requirements. 

Comment by 99942Apophis on Mar 12, 2021 8:38am
A side play I've been  considering more so lately with large pharmas being removed from Accelerated Approval voluntarily or not is somewhere down the line IF this company (TLT) starts to eat into big pharma's cancer related revenue a bear pharmaceutical ETF could be worthwhile. Mind you I will only buy into that or maybe look at the most vulnerable ones and pick up some ...more  
Comment by Jaro1977 on Mar 12, 2021 8:59am
https://www.fiercepharma.com/marketing/fda-convenes-adcom-to-review-accelerated-approvals-failed-trials-threatening-merck  
Comment by tamarindo1 on Mar 12, 2021 9:56am
Additional Indications being added to drug labels is an old, ongoing procedure by Big Pharma covering a variety of of drugs. When caught they pony up their multi-billion dollar fines and carry on as per normal. As this was under accelerated approval they have been nailed prior to profits exceeding fines. Adding additional indications to drug labels is a normal procedure, and as long as profits ...more  
Comment by enriquesuave on Mar 12, 2021 12:40pm
Good to see that the FDA is challenging Big Pharma on these drugs.  Even if BP has ways to put pressure on the FDA, we see that in the end data is King.  May TLD-1433 be the supreme King in bladder cancer with unparalleled data, and GBM and NSCLC to follow.
Comment by Jaro1977 on Mar 12, 2021 12:43pm
All hail the KING TLD-1433, Rutherrin, RuVaCare!!!!!!!!!!!!!!!!! And QUEEN DR. SHERRI McFARLAND of course!!!!!!!!!!!!!!!!!!!!!!!!
Comment by Rumpl3StiltSkin on Mar 12, 2021 10:58am
I think a ton of this stimulus is going to find it's way back into the stock market, one prognosticator has pointed out that the biotechs have lagged the rest of the stocks so far in this broad rally. Also, small caps. I'd wait to short the market at least 18 months. Maybe 2 yrs for biotechs/small caps. This stim money will take time to work through.
Comment by 99942Apophis on Mar 12, 2021 11:38am
Rumpl3StiltSkin wrote I think a ton of this stimulus is going to find it's way back into the stock market, one prognosticator has pointed out that the biotechs have lagged the rest of the stocks so far in this broad rally. Also, small caps. I'd wait to short the market at least 18 months. Maybe 2 yrs for biotechs/small caps. This stim money will take time to work through. Great point ...more  
Comment by Rumpl3StiltSkin on Mar 12, 2021 1:06pm
I've thought the overall market has been in bubble terriroty for a while, yet it could have a ways to go before it pops. I do like your idea that a bear Pharma ETF will be a good play, in about a year. I think any big move into biotechs will sympathetically support Big Pharma for a while.
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Investor Presentation

The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 75 of 100 Patients Treated (Enrollment to be completed by end of 2024, with study completed by end of 2026)
     
  • Ground Floor Investment Opportunity in Multi-Billion Dollar Industry
     
  • Best-in-class treatment for NMIBC (according to interim clinical data)
     
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The Road to Saving Lives: Clinical Study Underway

  • Clinical Study with 72 of 100 Patients Treated (Enrollment to be completed by end of 2024, with study completed by end of 2026)
     
  • Ground Floor Investment Opportunity in Multi-Billion Dollar Industry
     
  • Best-in-class treatment for NMIBC (according to interim clinical data)
     
  • NMIBC (Non-Muscle-Invasive Bladder Cancer)
     

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