Akebia Therapeutics Inc To Discuss The Response To The FDRR Transcript

Feb 06, 2024

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May 30, 2023 / 12:30PM GMT
Operator

Good day, and thank you for standing by. Welcome to the Akebia Corporate Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

And I would now like to hand the conference over to your speaker today, Ms. Mercedes Carrasco, Senior Director, Investor and Corporate Communications. Ms. Carrasco, please go ahead.

Mercedes Carrasco - Akebia Therapeutics, Inc. - Director of Corporate Communications

Thank you, Chris. Welcome, and thank you for joining the call this morning.

Today, Akebia announced that we have received a written response from the Office of New Drugs of the FDA regarding our formal dispute resolution regarding the complete response letter received in March 2022 for vadadustat. Today, we will discuss the response, next steps in the regulatory process and provide a general business update related to vadadustat.

Please note that a press release was issued earlier today, Tuesday, May 30, detailing the response, and that release is available on the Investors section of our website.

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