RE:All 360 CR's seem to stay CR at 450 from the past.DJDawg wrote: Lots of great commentary regarding the most recent update.
The same ideas but put differently.
- Historically all 360 CR's seem to stay that way at 450
- The best two examples are the two patients from 1b who are CR x years now
- One way to think about the next round of data is to see the patients arriving at each time post.
- Looking below, from the last update to this new one, for 360 day, 4 new patients arrived at that time point as CR patients. No new patients arrived at that time post as NR or PR. In fact, one seems to have converted from PR to CR.
- There have been times when patients convert to CR later in the trial but there is at least one where they didn't stay CR (change to PR).
- I would argue that the 4 new CR arrivals at 360 consist of 3 CR's from day one and (maybe) a CR that may not be a CR from day one. Hard to say.
- all CR patients who have ever gotten to 360 stay that way at 450.
- that means that the most likely scenario is that the 4 CR's will become CR's at 450 and the most pessimistic scenario is 3 CR's at 450 day and 1 non-CR.
- therefore the the next update will show the following for the 450 day update
| In patient numbers | |
| | 450 day | 450 day |
| | Worst case | Best case |
| CR | 8 | 9 |
| PR | 3 | 3 |
| NR | 16 | 16 |
| either PR or NR | 1 | 0 |
| Total | 28 | 28 |
| | | |
| IN percent | | |
| | 450 day | 450 day |
| | Worst case | Best case |
| CR | 28.5 | 32.1 |
| PR | 10.7 | 10.7 |
| NR | 57.1 | 57.1 |
| either PR or NR | 3.6 | 0.0 |
| Total | 100.0 | 100.0 |
That is my analysis. Please disagree if you can see any flow in my logic. I'm not trying to be a cheerleader, but just reason things out as best I can.
IMO
Thanks...in my honest opinion & for the sake of scientific clarity, it would be helpful if "only" CRs & NRs are reported. PRs are irrelevant in the final analysis & they only add to this efficacy guessing game, which I regretfully have participated in. To help clarify true efficacy, I would simply report a PR as part of the pending data until that time it is determined to be either a CR or NR....there's no in-between.
Also, an NR at one point in time doesn't predict with 100% accuracy that the NR will persist at some future point in time. An NR after the first treatment could simply indicate unchanged disease that ultimately required the 2nd treatment in order to convert to a CR. Additionally, from a medical practice/real-world perspective, an NR that persisted even after 2 treatments could simply signify the need in the future for an additional treatment or shorter-interval treatments. I know for this indication the FDA is more interested in CR% & duration of CR%, but I think it's safe to say that for every patient afflicted with this terrible disease, "progression-free" survival & being able to avoid cystectomy ultimately takes precedence.
Not to be a cheerleader as well, but what makes our ACT so attractive to me is that we currently have a lot more flexibility with our treatment protocol compared to the competition (two treatments vs dozens for some of our competitors). If our ACT is approved, this should translate to medical providers having a lot more clinical/treatment flexibility. All IMHO. Good luck...