RE:New Data Format
Eoganacht wrote: The new format for presenting data at first seemed a little off-putting, mainly because it was difficult to compare previous data with current data so we can determine if we are doing as well as expected.
I am guessing that the biostatistics and regulatory organization helping Theralase compile the clinical data report for submission to the FDA in support of the BTD application advised making these changes to the presention of the data.
The chart in the MD&A is headed
Patient Assessment Visit and that's exactly what it is - a chart showing the assessments of patients at various time intervals. Only 12 patients have been assessed at 450 days and the chart shows only the results for those 12 patients. Patients previously assesed NR who have reached 450 days but were not assessed at 450 days are not shown.
This chart only shows Phase 2 patients. The 3 phase 1b patients previously included have been excluded.
For my own peace of mind I wanted to know how we are doing in terms of the old format. I put together the following chart by moving the totals forward 3 months, keeping the phase 1 patients and incorporating the new numbers. I have some uncertainty about how many patients moved from one time period to another, but I think this is fairly accurate. We're doing very much as we expected. It seems the sky is not falling.
| | 90 | 180 | 270 | 360 | 450 |
| Assessment | # | % | # | % | # | % | # | % | # | % |
| CR | 30 | 54% | 25 | 58% | 17 | 45% | 11 | 30% | 10 | 29% |
| IR | 6 | 12% | 8 | 18% | 6 | 16% | 2 | 5% | 2 | 6% |
| TR | 36 | 65% | 33 | 77% | 23 | 61% | 13 | 35% | 12 | 35% |
| NR | 19 | 35% | 10 | 23% | 15 | 40% | 24 | 65% | 22 | 65% |
| Total | 55 | 43 | 38 | 37 | 34 |
Like me, the old school format works too. Thanks for the numbers...
Looking at the Swimmer's plot, there are currently 19 patients who are planning to move forward with the trial (i.e. they have not yet been assessed at 450 days). Of those 19, 14 (74%) demonstrated a CR. Twelve of the CRs plan to move forward with the trial, which gives us a rolling CR rate of 63% of all currently active trial patients. The 90 day assessment of the 4 pending patients can only increase this rolling CR rate...
1 of 4 CR = 68%
2 of 4 CR = 74%
3 of 4 CR = 79%
4 of 4 CR = 84%
Though we are still dealing with a relatively limited sample size, the above trend is real & suggests the overall 450 day CR can feasibly reach the low to mid 30s, especially if you dismiss the first 12 undertreated, which the interim KM curve did not account for. All imo.