I wondered the same thing (the one ODAC member who voted against), there was some speculation it was the one statistics guy they had on the panel. Placing statistical supremacy above ehtical and pratical considerations i.e. placing statistical perfection ahead of the ethical and practical considerations. It would make sense. The arguments from MSB were beyond debate, particulalry the medical ones. I can imagine some stickler to statistical analysis lacking perspective beyond his rigid and impractical requirements.
There have been a few posts citing where the FDA over-ruled Committee approvals. I beleive they never have an ODAC decision and I'd like to see the overturn rates on 9-1 or 10-0 decisions (a 6-4 decision I'd get). I just can't see it happening on a treatment for children, where there are no alternatives, that was so well presented and reported.
MSB Trading 2020 - a new dawn, page-5947
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