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Vadadustat PDUFA Passed?

Here is a brief preview of this blast: 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.

About The Author

Matthew Maryniak

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President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.