In today's world the paths to FDA Approval are manyMay 31, 2023 - the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data, despite its March 2022 rejection of the drug because of safety concerns..
https://www.biospace.com/article/akebia-to-resubmit-anemia-drug-application-to-fda-after-initial-rejection/