RE:The first 25 PatientsEoganacht wrote: The first 20 patients have all had their 450 day evaluation and we know the results:
| Assessment | Patient Assessment Visit Day |
| 90 | 180 | 270 | 360 | 450 |
| Complete Response ("CR") | 45% 9 | 40% 8 | 40% 8 | 25% 5 | 25% 5 |
| Partial Response ("PR") | 15% 3 | 25% 5 | 5% 1 | 15% 3 | 10% 2 |
| Total Response ("CR + PR") | 60% 12 | 65% 13 | 45% 9 | 40% 8 | 35% 7 |
Once patients 21 to 25 have had their 450 day evaluations in the 4th quarter Theralase is going to submit the data of the first 25 to the FDA and request BTD (and possibly AA)
There are 5 patients to go. What are the best and worst possible CR rates Theralase could be submitting
The best case scenario would be if all 5 are CR - 5 out of 20 (25% CR) would become 10 out of 25 (
40% CR) and if the 2 PR patients were declared to be CR then it would be 12 out of 25 Patients (
48% CR)
The worst case scenario would be if the final 5 of the 25 were all NR and the 2 PR patients were not converted to CR. This would mean 5 out of 25 (
20% CR)
So the 450 day CR rate we will be submitting to the FDA for the first 25 patients will be somewhere
between 20% and 48% The actual final CR number will likely land somewhere in between. If we suppose just 2 of the final 5 are CR, and 1 of the 2 PR is converted to CR we will be submitting a 450 day CR rate of
32% This is a really great result for 450 days.
Even the worst case scenario of
20% CR at 450 days is better than what FDA approved Keytruda achieved at 360 days so IMHO we are going to get BTD from the FDA. Some day soon the market is going to realize where Theralase is headed and when they do we should see substantial stock price appreciation as FOMO kicks in.
Hi Eoganacht - I have to be a nuisance again and go back to my old schooling where 2+2=4.
You start off by saying the first "20" patients
have all had their 450 day evaluation -- and then you provide the chart.
Column 1 = 12, Column 2 = 13, Column 3 = 9, Column 4 = 8, Column 5 = 7.
What is the difference between these column totals and your target of "20"? i.e. where are the other patients?
Are they all NR or some other designation? Would it not be easier to understand if in fact each column equalled out to 20 as was your stated target number? Or do I once again not understand what it is that you are saying?