Considering this, in the Jan. 3rd article:
In November 2022, Theralase reported encouraging interim clinical data from the pivotal clinical study, with 53% (43 evaluable patients) achieving a complete response at 90 days; 29% (34 evaluable patients) at 360 days; and 28% (29 evaluable patients) at 450 days.
Including patients with an indeterminate response (negative cystoscopy and positive urine cytology, where upper of lower tract UCC has not been identified but is still under investigation by the clinical study sites) patients exhibited a total response are 67% at 90 days; 44% at 360 days; and 38% at 450 days.
1) CR @450-days for the optimized group:
Lets try to assess the CR @450-days in order to have a better understanding of where we could be heading, the more we had new patients.
29 evaluable patients = 3 from Ph. 1b + 12 undertreated + 14 optimized (p#13-p#26 as p#26 was in the Nov. 30 stats)
28% of 29 patients = 8.12 CR patients @450-days
Lets assume 0 CR patients @450-days from the 12 undertreated for a moment, to play this conservative.
That would be 8.12 CR patients @450-days - 2 CR patients @450-days from Ph. 1b (p#5-6). So 6.12 CR patients @450-days patients from the optimized group.
6.12 CR patients @450-days out of 14 from the optimized group = 43.7% CR patients @450-days
2) TR @450-days for the optimized group:
Lets try to assess the TR @450-days in order to have a better understanding of where we could be heading, the more we had new patients.
29 evaluable patients = 3 from Ph. 1b + 12 undertreated + 14 optimized (p#13-p#26 as p#26 was in the Nov. 30 stats)
38% of 29 patients = 11.02 TR patients @450-days
Lets assume 0 TR patients @450-days from the 12 undertreated for a moment, to play this conservative.
That would be 11.02 TR patients @450-days - 2 TR patients @450-days from Ph. 1b (p#5-6). So 9.02 TR patients @450-days patients from the optimized group.
9.02 TR patients @450-days out of 14 from the optimized group = 64.4% TR patients @450-days