RE:" Missing 18 Pending patients data"
wildbird1 wrote: Like almost everybody on this board, I have always thought that the 12 undertreated patients were influencing negatively the CR% data... not anymore, after reading the 2Q2020 & 3Q2021 Quaterly Newsletter, I did change my mind.
I am going agains the grain here by saying that there is absolutely no undertreated patients left in the study11 trial, or should I say, all the undertreated patients that were still in the study11 trial have all been treated with the optimized treatment protocol.
Let me explain.
If you take the time to read the 2Q2020 Quaterly Newsletter, you will see that 4/12 patients have been removed from the study11 trial, and the 8 undertreated patients left in the study11 trial, have by now all been treated with the optimized treatment protocol.Conclusively, except for the 3 patients from the 1B Study trial, all the patients in the Study11 trial have been treated with the optimized treatment protocol.
If all the patients in the study11 trial have been treated with the optimized treatment protocol, why is it that in the Nov 29, 2022 Newsrelease at 450 days the CR% is only 28%.
The answer could be as simple as, we are missing 18 pending patients data.
From the Nov 29,2022 Newsrelease.
The data at 450 Days are...
Complete response(CR)..............28%..............8 Patients.
Indeterminated response(IR).......10%..............3 patients.
Pending patients...........................62%............18 patients.
Evaluable patients........................100%...........29 patients.
Note:1) These 18 pending patients could not be all NR(Non Response) patients, as from the 3Q2021 Quaterly Newslletter(page 5), the non response% for the optimized patients group was very very low, approximately 6%NR(non response).
Note:2) only 6%NR( non response) is impressive, when you know that all the patients in the stud11 trial have been treated with the optimized treatment protocol.
In the Nov 29,2022 NewsRelease at 450 days we have the data on only 11 patients(8CR+3IR), not the complete data on 29 patients.
Of the 11 patients 8 are CR = 73%CR.
Note:3) Is it possible for the 450 Days CR% to be higher than the 90 Days CR%? The answer could be yes, as the 450 days patients have received 2 treatments, and some of the IR patients coud have become CR patients after the second treatment.
To Sum Up...
Take the time to go on TLT website under Investors Ressources (Quaterly Newsletter), re-read the
2Q2020 Quaterly Newsletter(bottom of page 2...of the 8 patients eligible....).
And the 3Q2021 Quaterly Newsletter(page 5...90 day preliminary interim results on 18 optimized patients...NR(no response 6%))
After reading these 2 Quaterly Newsletter you will come to the same conclusion as DR.Mandel "We have impressive preliminary results"(Pressrelease June 24,2022).
Only the release of the complete data on the first 25 optimized patients will prove all the above.
Hi wildbird...it is my understanding that an evaluable patient is one who has already met statistical analysis criteria (i.e. has already had his 450 day assessment) & can therefore be included in the efficacy data. I am therefore assuming the 18 pending patients = NR patients...this NR group was simply not included in the results/data chart as presented.
The CR%s are nonetheless excellent considering that "all" of the first 12 patients had received a "non-optimized first treatment", & 3 of the those 12 had already received a "second non-optimized" treatment. Iam anticipating the 450d CR%s should still get a bump up from 28% as more "fully" optimized patients get assessed (those who have received "two" optimized treatments). I also believe we could see a bump over time as PIs get more experience with this ACT/improved protocol...practice makes perfect.
The above is my understanding of the data & All imo. Good luck...