Post by
DJDawg on Oct 20, 2023 4:11pm
update on stats in relation to FDA advisory panel
The FDA panel from way back indicated support for a drug that could achieve:
- 40%-50% at 6 months (note that they don't list 3m CR or CR at any time)
- 30% for 18-24 months, with the lower bound of the 95% confidence interval excluding 20%
UPDATED FROM OCT 16 NEWS RELEASE
The statistical angle is where it gets tricky. My math says for 95% confidence interval we are at:
Total group (optimized and non-optimized)
3m: 45-71%
6m: 43-69% (NOW meet this one on the lower bound, whereas not quite before)
12m: 21-50.6%
15m: 17.9-48% (not quite 20% on the lower bound since for the margin of error for 42 patients is plus or minus 15.13%)
The only thing holding back the 15 m data from looking better is that the smaller the sample size, the wider the error margins are.
My hunch is that when the pre-BTD review was looking at data, the probably asked for 18m data on the patients as the FDA panel listed 18m as the wish list from way back. This would mean contacting the centres and asking for updates on the patients in question.
Comment by
greaterfoolFred on Oct 20, 2023 4:45pm
Thanks for doing all of the math DJ. You may be right about the 18 months, but that would be pretty crappy of the FDA after aleady approving the study design.
Comment by
Rumpl3StiltSkin on Oct 21, 2023 8:43am
Doesn't this 18 month data look even better than the 15 month data? Seems to me BTD is coming. Maybe just a bit longer.
Comment by
DJDawg on Oct 21, 2023 12:12pm
I don't think they ever published 18m data. But as far as we know everyone who was continuously CR from 90 to 360 stayed CR thereafter. This would be an easy PR news release BTW. RDW could "congratulate" all the CR patients for continuing to be cancer free after the 450 time point :)