Pandora wrote: Now that we are into a 4 day weekend can I go back to basics in trying to interpret the news release?
Prior to the first chart there is the following statement: (I have since been debating with myself if the subsequent chart titled "Study II Clinical Study Data" is for 38 total patients or only 35 Study II patients). Can someone confirm? Also there is no date on this chart
"As previously announced, Theralase® successfully completed a Phase Ib NMIBC Clinical Study (“Study I”), which enrolled and provided the primary study treatment, at the therapeutic dose, for 3 patients. To date, Study II has enrolled and provided the primary study treatment for 35 patients, which when combined with the Study I data, leads to a total of 38 patients, who have received at a minimum, the primary study treatment."
Study II Clinical Study Data:
| Assessment (Days) | Complete Response (“CR”) 2 | Partial Response (“PR”) 3 | Pending 4 | CR (Evaluable Patients) 5 | Total Responders (CR + PR) 6 | Potential Responders (CR + PR + Pending) 7 |
| 90 | 44.7% | 15.8% | 10.5% | 50.0% | 60.5% | 71.1% |
| 180 | 31.6% | 15.8% | 28.9% | 44.4% | 47.4% | 76.3% |
| 270 | 23.7% | 5.3% | 42.1% | 40.9% | 28.9% | 71.1% |
| 360 | 13.2% | 7.9% | 47.4% | 25.0% | 21.1% | 68.4% |
| 450 | 13.2% | 5.3% | 47.4% | 25.0% | 18.4% | 65.8% |
In the chart, on the assumption it represents all 38 patients, I derive from the percentages that at the 90 day period "44.7% CR" represents 17 patients + "15.8% PR" represents 6 patients + "10.5% Pending represents 4 patients (27) -- where are the other 11?
My logic then breaks down because 44.7 + 15.8 + 10.5 only totals 27 patients. (71% of the 38) which agrees with the figure at the end of the chart.
Being repetitious where are the other 11 patients -- is there not a category for them? Is this suggesting they have been treated but have not yet reached the 90 day target? If that is true what is the difference between them and the "Pending"? The paragraph above the chart says all 38 have been provided the primary study treatment. Is there a "wait" time before you get categorized as "Pending"?
As you can tell I'm confused -- and likely not alone.
Based on this next statement whereas Chart One appeared to be for 38 patients for each line interval the data in Chart Two varied for each line as follows:
"The Study II optimized treatment patients, who received either an optimized primary study treatment or optimized maintenance study treatment consisted of: 23 patients at 90 days, 26 patients at 180 days and 27 patients at each of 270, 360 and 450 days."
This then confirms the reference to "Primary" and "Secondary" further down in the NR where they suggest the 90 day "Primary" data (44.7%) in Chart One is on 38 patients whereas the 90 day "Primary" data (52.2%) in Chart Two is only for 23 patients.
They then go on to suggest the "Secondary" 450 day data (13.2%) in Chart One is for 38 patients and the "Secondary" 450 day data (3.7%) in Chart Two is for 27 patients.
I am assuming Chart Two for the most part does not include Patients 1 to 3 from Phase 1b or all 12 of the first under-dosed patients from Phase II (Study II) -- but that's a guess. Not sure why it varies from 23 patients to 27 patients. Maybe it will become clear. Also have not really figured out how some lines are referred to as Primary and others as Secondary.
I will leave it at that for now while I sit and scratch my head some more and try to rationalize it all. My complements to all of you that have been able to sort it out. Very astute!