RE:update on stats in relation to FDA advisory panelDJDawg wrote:
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.
Dawg, really appreciate the stats you put together. Since you work in the industry and seem to have some more informed thoughts on what's at play behind the scenes, is this common that the FDA criteria is out of alignment with the study's stated objectives? None of the prior MD&A's make mention of this more rigorous FDA panel stipulation and yet if that is guiding the ultimate decision for advancement, would it not be commensurate on the company to provide that transparency in the MD&A language? Perhaps I'm in the minority but I am quite tired of the goal posts moving...