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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 greaterfoolFredon May 02, 2023 12:57pm
141 Views
Post# 35425425

RE:The missing 450 days patients.

RE:The missing 450 days patients.It's time to stop talking about this nonsense.  We know enough about the real data to know that it is good.  The data justify BTD.  Bring it on.

wildbird1 wrote: In the Nov,2022 Swimmer Plot TLT had 19 patients at 360 days.
From the above we should conclude that in the April,2023 Swimmer Plot TLT would at the least have 19 patients at 450 days.

The reason there is only 12 patients at 450 days is because of the date the data for the April,2023 Swimmer Plot were collected and compiled.
In the Feb2,2023 Pressrelease TLT said" TLT announced today that its clinical (study11) (interim) data has been accepted by the American Urology Association(AUA).
The AUA annual meeting will take place between April,28 to May1,2023.
In Nov29,2022 these patients had completed their 360 days data + 60 days(Feb,2023) = 420 days.
In short these 19 patients at the moment the April,2023 Swimmer Plot data were compiled(Feb,2,2023)...These 19 patients had only completed 420 days, not enough to be included in 405 days data.

As we speak, these 19 patients have completed their Efficacy, Safety and 450 days Duration data.

Remember it is the FDA that define the rules, and the FDA said Efficacy is defined as "CR at any point in time".
The reason the FDA use the "CR at any point in time, is because some patients are old  and their immune system is so weak that the chance that they respond to any treatments are almost nil ( the FDA know that they are untreatable) but there is nothing wrong to giving these patients a chance(nice gesture from TLT).
The FDA know that with these kind of patients using only the CR% at 450 days to evaluate TLT treatment would not give a true representation of the Efficacy of TLT treatment, that is why the FDA use the "CR% at any point in time".

The "CR at any point in time" for these 19 patients is....
14 Patients at   90 days.
  0       "       at 180 days.
  2       "       at  270 days.
Total  16/19 patients = 85% "CR at any point in time".
+3 patients from study1b trial(2/3 are CR) total 22 patients .

Note: Data on 22 patients at 450 days is enough to apply for BTD.


       
   


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