essentially going to be a question of whether the perceived outcome benefits outweigh the perceived input risks.
i'm not so sure they do. Others have alluded to notion that the FDA have approved treatments with similar risk in the past, but i personally don't know of any such precedent. Then again, I'll be the first to admit i'm not an expert on previous FDA decisions.
If the FDA do approve (and there is no similar/alike decision for input risk - outcome benefit cases) then it may set a dangerous precedent for them. And i doubt they'd be willing to go out on a limb if there are any other notable risks (eg. previous adult placebo trial outcomes...) .
MSB Trading 2020 - a new dawn, page-3649
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