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 @90-days for the optimized group:
Lets try to assess the CR @90-days in order to have a better understanding of where we could be heading, the more we had new patients.
43 evaluable patients = 3 from Ph. 1b + 12 undertreated + 28 optimized patients
53% of 43 patients = 22.8 CR patients @90-days
Lets assume 0 CR patients @90-days from the 12 undertreated for a moment, to play this very conservative.
That would be 22.8 CR patients @90-days - 2 CR patients @90-days from Ph. 1b (p#5-6). So 20.8 CR patients @90-days patients from the optimized group.
20.8 CR patients @90-days out of 28 from the optimized group = 74.3% CR patients @90-days
2) TR @90-days for the optimized group:
Lets try to assess the TR @90-days in order to have a better understanding of where we could be heading, the more we had new patients.
43 evaluable patients = 3 from Ph. 1b + 12 undertreated + 28 optimized
67% of 43 patients = 28.8 TR patients @90-days
Lets assume 0 TR patients @90-days from the 12 undertreated for a moment, to play this very conservative.
That would be 28.8 TR patients @90-days - 2 TR patients @90-days from Ph. 1b (p#5-6). So 26.8 TR patients @90-days patients from the optimized group.
26.8 TR patients @90-days out of 28 from the optimized group = 95.7% TR patients @90-days
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More realistic though ...
But my assumptions of 0 out of the 12 undertreated patients had any results (were all NR) inflates these % a bit. Assuming 3 out of 12 undertreated had lets say PR (partial responses), that would rather give these results:
That would be 22.8 CR patients @90-days - 2 CR patients @90-days from Ph. 1b (p#5-6) - 3 TR patients @90-days from the undertreated.. So 17.8 CR patients @90-days patients from the optimized group.
17.8 CR patients @90-days out of 28 from the optimized group = 63.5% CR patients @90-days
That would be 28.8 TR patients @90-days - 2 TR patients @90-days from Ph. 1b (p#5-6) - 3 TR patients @90-days from the undertreated. So 23.8 TR patients @90-days patients from the optimized group.
23.8 TR patients @90-days out of 28 from the optimized group = 85.0% TR patients @90-days