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 |