RE:The Good News "For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days."
The FDA will take these percentages into account as they compare the data of the 1st 25 patients (which includes Non-Optimized patients and anomalies which should not be counted and removed IMO ) to the Optimized treated patients with much higher CR rate at 90 days. These percentages may potentially even increase over time as anomalies( patients who were wrongly dropped from trial and patient who died) are removed. All IMO
enriquesuave wrote:
"For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days."
This is very telling so far, especially given that we have several undertreated patients in the first set of 12 patients. So numbers may get better as we have more Optimized patients treated. On Optimized patients we are seeing 60% CR and 18 % PR at 90 days. I expect and hope for around 70-75% CR at 90 days, that is as more patients are treated and we get slightly better numbers and if 50% of PR patients convert to CR. (At the very least 65%CR. ). If 56% of my numbers remain CR at 360 and 450 days, then that would be 39-42% CR overall. Pretty Amazing and should grant us (AA )Accelerated FDA approval after perhaps 40 or so patients if that trend continues obviously. My numbers were correct. The benchmark of 30% (12 months CR rate) established by the International Bladder Cancer Group which was deemed possibly too high and unattainable may be badly beaten by TLD-1433 One and Done treatment if we hit 39-42% CR. Would be the best Single Agent by far beating Keytruda at 19%, Vicinium at 17%, Adstiladrin at 24% and CG0070 at 29%, with all of these other agents requiring many, many more instillations and potentially much lower efficacy. At the very least if we get 65% 90 days CR, then that would still be about 36.4% CR, still much better All IMHO. GLTA.