RE:450 Day Assessment Results for the First 13 Phase 2 PatientsI follow your math and logic. If we then look at the Nov 2022 data for patients @450 day excluding the three patients in the phase 1b trial I get the table below; note IR is equivalent to PR previously
Complete Response 6 23.0%
Indeterminate Response 3 11.6%
No Response 17 65.4%
Total treated 26 100.0%
If we now subtract the data in this table from the one in your post what we will get is a very close approximation as to the current trend in the trial results of just the optimized treatments.
CR 4 31%
IR 1 8 %
NR 8 61%
tot 13
The CR+IR rate = 39% which is trending higher.
Now the table from Nov 2021 includes 1 patient that received optimized treatments and we do not know their result. If we assume they were NR or CR/IR we can adjust the table accordingly and subtract from the Nov 2022 table to establish the current trend range.So Table from Nov 2021 becomes
CR 2
PR 2
NR 8
tot 12
assuming the first optimized patient was NR and
CR 1
IR 2
NR 9
tot 12
assuming the first optimized patient was CR/IR
Subtracting the data from Nov 2022 to get the range of the trend in the patients receiving the optimized treatment
CR 4 28.6%
IR 1 7.1%
NR 9 64.3%
tot 14
35.7% CR+IR would be on the low end of the range for the optimized group
CR 5 35.7%
IR 1 7.2%
NR 8 57.1%
43.2% CR + IR would be on the upper end of the range for the optimized group.
As per the last financial summary;
the patients who have achieved an Indeterminate Response (“IR”) are being further assessed via Computerized Tomography (“CT”) scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma (“UCC”) or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.
the Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis.
If the patients (up to 3) that were deemed IR had to undergo additional tests could this not have pushed back the timeline for collecting the data and completing the application for BTD?
This seems like a more logical reason than the company waiting for another quarter to have more data from the optimized group