RE:RE:RE:RE:Very Good News!DJDawg wrote: I was curious about the drop off in CR over time. I couldn't find it for the most recent data but interestingly the 157 patient response mentioned above is similar to the smaller patient data reported earlier in 2021. 151 is very similar to 157 but the CR is different between the 51% CR reported here vs the above reference.
| Recurrence-free survival (months) | CIS + /- Ta/T1 (n=103) | Papillary disease (n=48) | Total (n=151) |
| 3 | 53,4% | 72,9% | 59,6% |
| 6 | 40,8% | 62,5% | 47,7% |
| 9 | 35% | 58,3% | 42,4% |
| 12 | 24,3% | 43,8% | 30,5% |
In real terms
90 day CR was 59.6% OR 51% (two different numbers out there) vs our 53% (non optimized included)
180 day CR was 47.7% vs our 45%
270 day CR was 42.4% vs our 41%
360 day CR was 30.5 vs our 29%
450 day not reported from this group but above say 46% of initial 51% which is 23.5% vs our 28%
So very very similar. Our still has 1-2 and done advantage. Ours, when optimized is obviously higher.
So much time and success lost on those 12 non-optimized patients. sigh.
Ultimately, it should only be the optimized patients that the FDA will consider in determining if we are AA eligible or not imo. Even when considering the undertreated, our 450 day data to date reflects a 19% improvement in CR compared to Adstiladrin, which I would consider significant. If you look at only the optimized (relevant) data, the percent improvement in CR is 100% (47% vs 23.5%...includes the two Ph 1 patients who received a full dose single treatment). The FDA now has a valuable glimpse of what a difference an optimized/proper dosing makes. Based on the above, one can reasonably conclude that this ACT not only stands alone in terms of treatment efficacy & efficiency, but it also has great potential in improving upon these metrics with minor modifications made in drug composition (using our patented library of drugs) & number of treatments, which points to perhaps this ACT's greatest advantage = Versatility....All imo.
Any frustration/perceived time lost due to the first 12 undertreated may have paradoxically served our goals well. Though I admit I'm an optimist, I'm an objective one : ). Good luck...