Theralase Technologies Inc. V.TLT

The first 25 patients.

[wildbird1]

Here is a little challenge for anybody on this board.
Find just one PressRelease were TLT said that for BTD application, TLT need more than 25 patients data???
You wont find any, from the first day of phase11 trial,TLT has always repeated the same phrase.
" The company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after the completion of the 450 days assesment for 25 patients".

Here are interesting numbers on the first 25 patients. I did use the same numbers as the last Swimmer Plot.
-CR at any point in time for the first 25 patients= 21/25 patients=84% CR at any point in time.
-Here is a number that went unnoticed, the response rate(patients that did respond to the treatment at one point in time).
100% of the first 25 patients did respond to TLT treatment at one point in time.
Some for just 90 days, but they still did respond. What would have happened if these patients had received a third treatment?
-For these 25 patients, safety was 100%.

Think about this...
As we speak the FDA has no treatment for the kind of patients TLT is treating( even Adstiladrin doesn't work, as patients who are immunosuppressed, or immune-deficient should not come into contact with Adstiladrin), TLT doesn't have this kind of restrictions.

[99942Apophis]

Regardless of the original statement of the first 25 patients wildbird1,  something has changed or happened that might have altered that number.  We don't know if the FDA needs a slightly different data configuration for Theralase to receive BTD & AA which is what I believe might be in the works and would explain the extra time factor here. Honestly I don't care what the

[Legit62]

Would have to agree with you Apophis, something had to change in what FDA wanted or else we would have BTD by now since it was supposed to be applied for 1st quarter, not complaining because it appears as time goes on on numbers improve, and i also feel we will get both BTD and Aa together, hopefully by 4th quarter without big dilution

[skys1]

Agree Legit, good post.They were supposed to have the data to submit the BTD app end of Dec. or biggining 4th Q. That was 5 months ago. Since Breakthrough was achieved, we know they are in frequent contact with the FDA. Something major had to have occured in discussions with the FDA for something that sunstantial a change to occur. Hopefully it is a positve change. BTD & AA at the same time

[Legit62]

One last thought on that skys1, it could just be that the data has to be presented in a certain format that satifies the FDAs requirement to grant us both BTD and AA, and tlt needed to dot all the EYES, AND they figured lets get it right since we all know there has been communication along the way with FDA, i do believe we are real close,IMO.  Bought more on the drops

[BlueFranky]

Apophis  and Wldbird- again I want to thank both of you for all of your contributions here. Godspeed, TLT!

[wildbird1]

99942Apophis, thank's for your reply..., In the last 3 financial, August 29,2022. Nov      29,2022. April     26,2023. When talking about the BTD update, TLT mentioned 25 patients every single time. That is a good indication that the 25 patients number didn't change.

[2b7f6fab]

Always appreciate your contributions to my knowledge base.  You and several others on this message for over ten years now.

[Lesalpes29]

Probably I'm wrong but I'm on the side of a glass full. BTD-AA will be announced together. FDA understand the urgence of TLT's act for patients. Very close to know, it's not time to leave the boat. GL