RE:RE:RE:RE:Potential Rise Well stated. As well I think we can really count 14 or at least 13 invalid patients from 1st set of 29. As 12 were severely undertreated, but afterwards 1 patient who died of HF was counted as NR, and 1 of the 3 patients from PH1 was also not given an optimized treatment and was probably invalid due to metastatic disease unrelated to bladder. All IMO, so 13 or 14 out of 29 patients are not really representative of our treatment. But still we are beating every single agent out there.
Eoganacht wrote: Hi consultant99 - with all of the BCG-unresponsive NMIBC treatments we have been talking about on this board the initial CR rate declines over time.
But there is more going on with our trial that further explains the CR drop at 450 days.
Of our
43 evaluable patients at 90 days 53% exhibited a complete response. The
12 initially undertreated patients represent
23% of these 43 evaluable patients.
But as the trial progresses, these
12 undertreated patients represent an increasingly larger percentage of the total patients evaluated.
Of our
29 evaluable patients at 450 days 28% exhibited a complete response. The
12 initially undertreated patients represent
41% of these 29 evaluable patients.
Over time our
CR percentage at both
90 days and
450 days should improve as the initially undertreated 12 patients become an increasingly smaller percentage of evaluable patients.
consultant99 wrote: Interesting point raised about more than 2 treatments.
I have wondered if any patients so far that were NR after their first treatment achieved PR or CR after a second treatment. If not is this a limitation for the technology
I also wonder why after 450 days the CR rate drops below the 90 day level even though patients that did achieve CR go through a second treatment.
I thought there was the potential for an immune response; I wonder what the outcome was for those patients in the trial after 450 days.. Would the company or the FDA have access to the information?