I chose "alive" because, well, HN is not always the best at biological nuance.
But there's a few major concerns:
1. Most preparations are bespoke. The FDA has made some headway with this because of fecal transplants, but it's still a problem.
2. Phages evolve. That's one of the benefits of them. Generally speaking, self-adaptive medications are not something we have a good regulatory context for.
3. They need culturing, isolation, identification, etc. and those are "wet lab" things.
But there's a few major concerns:
1. Most preparations are bespoke. The FDA has made some headway with this because of fecal transplants, but it's still a problem.
2. Phages evolve. That's one of the benefits of them. Generally speaking, self-adaptive medications are not something we have a good regulatory context for.
3. They need culturing, isolation, identification, etc. and those are "wet lab" things.