Ardelyx Inc (ARDX)

[Cosa]

CEO Mike Raab:
In addition, last quarter, we experienced an overwhelmingly positive Cardiorenal Advisory Committee vote supporting the benefit of XPHOZAH, which was then followed by the Office of New Drugs, granting our appeal and instructing the Cardiorenal division to work with us on an appropriate label for XPHOZAH.

We are moving quickly towards our NDA resubmission, and in mid-February, we held a Type A meeting with the Cardiorenal division. It was a very positive discussion and we are really appreciative of the time and responsiveness of the FDA. We are now completing our work on the NDA for XPHOZAH and are on track for resubmission early in the second quarter.

As we have said before, our base case expectations or that this will be a six month Class II review. We of course are hopeful that it could be shorter. Regardless, we are well-positioned and will be ready to launch in the second half of this year if approved.