Post by
wildbird1 on May 02, 2023 10:44am
The missing 450 days patients.
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.
Comment by
Alamir1111 on May 02, 2023 11:06am
Good post Could it be that there is a protocol for practitioners to follow Example looking at patients med history age etc.and determine the custom treatment required. Remember a boost in immune system is a blessing for some killer for others
Comment by
Alamir1111 on May 02, 2023 11:44am
The beuty of this technologie is.We can dial it up to blast cancer to ions. Or dial it down just to slow cancer growth and save bladder called compasionate care
Comment by
BlueFranky on May 02, 2023 11:07am
Brilliant, Wildbird1. Thank you!
Comment by
greaterfoolFred on May 02, 2023 12:57pm
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.
Comment by
Oilminerdeluxe on May 02, 2023 1:55pm
Thank you, Wildbird. Great read.