RE: FDA and NCI changes8 Apr 2023 21:10
Great interview I think it does sound it could apply to ava6k.
"But let me give you an example. First, I would say this is not the right place for first in human studies, early drug development, early biomarker development. But let's say you had approved drugs that are being tested for a new application and you really don't need a re-abrogation of the safety data. These are drugs that you have a vast amount of experience with in other diseases, and you already have some preliminary data that you have efficacy in the question that you're trying to answer.
In that circumstance, you could create a really streamlined clinical trial in which you really focus on the question at hand, and you could forsake or forego a lot of the data that's collected in any study and that frequently in any study is really barely used."