RE:RE:Numbers & Percentages of Evaluable Patients Agree....And kudos to our ACT if we are granted a BTD based on data that derives from a significant % of undertreated patients...this would be further testament to the potency & potential of our ACT.
However, the grant of an AA & the publication of trial results are at a whole different level. Such a milestone achievement (AA) & its publication should ultimately be based on the pertinent/valid data...data that represent the final/accepted clinical protocol. Fortunately, the underdosed group was relatively small, & in the final analysis, I can only hope the FDA exercises its scientific integrity. This underdosed group of data needs to finally be laid to rest where it can no longer obfuscate & potentially skew the "real" data in question. Post FDA/peer review, we shouldn't have to see any part of that headache again, regardless of size.
enriquesuave wrote:
Excellent summary and comparison. When we look at these numbers, we must remember that they include the 1set of 12 undertreated where 5 were dropped without a 2nd optimized treatment and 1 patient who died of unrelated cause. So at 360 days the 9 CR out of 26 could really be 9 out of 20 with 3 out of 20 PR. Numbers are getting better quite significantly, it this keeps up we can really shine at next data readout PR. All IMHO
Eoganacht wrote:
| May 30, 2022 - Number of Patients |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 17 | 16 | 10 | 5 | 5 |
| PR | 8 | 7 | 2 | 4 | 2 |
| TR | 25 | 23 | 12 | 9 | 7 |
| NR | 12 | 9 | 14 | 14 | 15 |
| Total Evaluable | 37 | 32 | 26 | 23 | 22 |
| | | | | | |
| May 30, 2022 - Percentages |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 46% | 50% | 39% | 22% | 23% |
| PR | 22% | 22% | 8% | 17% | 9% |
| TR | 68% | 72% | 46% | 39% | 32% |
| NR | 32% | 28% | 54% | 61% | 69% |
| Total Evaluable | 37 | 32 | 26 | 23 | 22 |
| | | | | | |
| August 29, 2022 - Number of Patients |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 19 | 16 | 13 | 9 | 5 |
| PR | 6 | 9 | 7 | 3 | 3 |
| TR | 25 | 25 | 20 | 12 | 8 |
| NR | 13 | 9 | 12 | 14 | 16 |
| Total Evaluable | 38 | 34 | 32 | 26 | 24 |
| | | | | | |
| August 29, 2022 -Percentages |
| | | | | | |
| | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days |
| CR | 50% | 47% | 41% | 35% | 21% |
| PR | 16% | 26% | 22% | 12% | 13% |
| TR | 66% | 74% | 63% | 46% | 33% |
| NR | 34% | 26% | 37% | 54% | 67% |
| Total Evaluable | 38 | 34 | 32 | 26 | 24 |