Crutial 450 day data.The 18 optimized patients 450 day data are crutial for the BTD application in Dec 22. Let's see why.
First what we know.
-In Dec 22, 18 optimized patients will have completed their 450 day data.
-In Dec 22, TLT will submit data on 20-25 patients for BTD application.
-The treatment protocol that has been approved by the FDA, is the "Optimized Treatment Protocol".
- With the "Optimized Treatment Protocol" approved by the FDA, we can easily assume that the 18 optimized patients 450 day data will be the first data that will be included in the 20-25 patients data that TLT will submit to the FDA for BTD approval.
-From the 1Q2021 Newsletter, we know that once a patients has obtained a CR(Complete Response), the duration of the response remain fairly durable(Approximately the same at 180,270,360 day...etc).
1) 18 Optimized patients CR%.
From the 3Q2021 Newsletter, we know that the 90 day CR% on 11 optimized patients(18-7 pending=11 patients) is 8CR/11patients=73% CR.
Let's extrapolate for 18 optimized patients, 18x73%=13 CR patients/18 patients.
2) From the 3 patients in the Phase 1b Study...(included by TLT in the phase 11 study data) we have 2CR patients.
3) From the 12 undertreated patients we have 3CR patients(25%).
Remember once a patients get a CR, the duration of the response remain fairly the same.
Dec 22, 20-25 patients CR%.
The 20-25 patients data that will be submited to the FDA in Dec 22,could be as follow.
13 CR patients(from the 18 optimized).
+5 remaining patients (from the 18 optimized).
+2 CR patients (from the Phase1b study).
+1NR patient (from the Phase 1b study).
+3 CR patients (from the 12 undertreated).
+1 NR patients (from the 12 undertreated).
Grand total 25 patients.
18 CR patients/ 25 patients= 73%CR in Dec 22.
All the above could explain why Dr.Arkady Mandel, in a June 24,2022 PressRelease said " The success in the Phase 1b NMIBC clinical study, has led to the impressive preliminary results demonstrated in the Phase 11 NMIBC clinical study".
Note: Dr.Mandel gave us a big clue when he said " has led to" indicating that these impressive preliminary results are genuine, and only need to be compiled and certified in Dec 22.
Dec 22.
Very soon.