Q the FDA decides to approve drugs, whether the, whether the benchmark is better than a placebo, better than nothing, or better than the standard of care. Um, how do you, how do you see the FDA's mandate In drug development, what is their goal? Are they trying to protect certain, certain IP structures by limiting the access to drugs, or is it more purely based on safety and efficacy broadly?
A Yeah. Um, I think, you know, so we've had conversations with the FDA and at the end of the day, the FDA is really a group of people trying their best to approve drugs that work. Um, and then, uh, you know, rejects drugs that might have safety issues or are the same as placebo. Um, so for us working in rare disease, a lot of the times we are up against placebo or even historical controls, um, because there's usually no approved treatment. Um, in these specific diseases. So it's much easier to get a drug approved there versus if you work in, you know, cancer, which is very common, um, like breast cancer. Um, there's already so many drugs that are approved and effective that you have to run really long trials against drugs that already work. Um, and that ends up being extremely costly, extremely expensive. And there's some debate about, you know, is there a way to get around this five, six year trial?
AI assessment note: “the FDA is really a group of people trying their best to approve drugs that work”