10 ms·
While this is a promising first start, it looks like it's a long way from being a working, FDA approved therapy. This sounds like it's entering Phase 1 testing
by losvedir 16y ago
While this is a promising first start, it looks like it's a long way from being a working, FDA approved therapy.
This sounds like it's entering Phase 1 testing. Phase 1 testing is where the drug is tested on healthy volunteers to monitor its effects on humans and whether it's safe and could potentially work. Next it moves on to Phase 2, where the drug's efficacy is tested in addition to safety, in a small number of patients. If a drug succeeds there, it will then move into Phase 3 trials with, usually, hundreds or even thousands of patients. FDA approval generally requires two such Phase 3 trials to succeed. The whole process can take ten years and drugs can and do frequently fail along the way. I wish I had the statistic on hand, but I'd estimate less than 20% of drugs entering Phase 1 trials make it all the way.