The vadadustat PDUFA date was on March 29, 2022; however, no press releases have been observed by Otsuka/Akebia nor has anything been posted on Drugs@fda. As such, it remains unclear if FDA will still approve the NDA in the coming days, issue a CRL, or potentially extend the PDUFA date. Presumably, the companies will have to issue a press release once they officially hear from FDA. Below, FENIX provides brief thoughts on the missed PDUFA date.