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The FDA requirements for the original clinical trial were wild: "...the FDA required them to find a cohort of 300 healthy 18-30 year olds who lived alone, not n
by queuebert 3y ago
The FDA requirements for the original clinical trial were wild: "...the FDA required them to find a cohort of 300 healthy 18-30 year olds who lived alone, not near a school zone, and had fully removable teeth."
I can see why this makes sense, but no wonder they failed at enrolling the cohort.
- tim333 3y ago"fully removable teeth"?
- smsm42 3y agoFor FDA, never permitting it is a completely acceptable outcome, and that's why it probably will never be permitted in the US. Unless somebody will find a reason to spend many billions of dollars to make it happen, which I don't foresee happening. I wonder if there's a chance in other countries, or they have their own FDAs?
- deleted 3y ago[deleted]
- konschubert 3y agoWhy the "not near a school zone"?
- anticensor 3y agoBecause of ethanol?
- scarby2 3y agoMaybe. You could possibly now fall foul of certain alcohol production laws....
- bagels 3y agoMaybe some attempt to prevent a contagion that would rapidly spread to many households through the children?
- v8xi 3y agoThat is a good question. I couldn't find a citation for the original comment, but my guess would be either that they want an unbiased cohort OR, since its a bacterial treatment, they wouldn't want to risk the spread and possibly contaminating children after the trial was done.