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No, this hasn't gotten anywhere near human testing yet. The FDA isn't involved.

FDA rules increase barriers to entry to the market, resulting in fewer companies (especially fewer smaller companies) who would be interested in funding such a project.

If you got DRACO to work in animals, there isn't a pharmaceutical company (or VC) on the planet that wouldn't buy you a small island just to get you to the table. This is probably the worst example you could choose for trying to demonstrate FDA regulations chilling development next to CRISPR.

It's the in vitro -> in vivo part that they're anxious about wasting money on, not the FDA process.

But FDA rules loom large in every decision in medicine. Avenues of research that are going to produce results that will be difficult to bring to market are likely to be abandoned even before the government is involved by law.

That's not necessarily a bad thing.

Obviously it will be in the future, which deters any small scale seed investment...

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