Acer Therapeutics Inc. (ACER) is attempting to get FDA approval for ACER-001, in the indication of urea cycle disorders, for the second time.The U.S. regulatory agency had declined to approve ACER-001 in June 2022, stating that satisfactory inspection of its third-party contract packaging manufacturer is required before the drug could be approved.Addressing the concerns raised by the FDA, the company resubmitted the New Drug Application for ACER-001 in July of this year, designated as a Class 2 resubmission, with a decision date set for January 15, 2023.If approved, ACER-001 will have to compete with Horizon Pharma’s Ravicti and Buphenyl. Ravicti generated sales of $238 million and Buphenyl had sales of $5.3 million in the nine months ended Sep.30, 2022.Acer is developing ACER-001 in collaboration with RELIEF THERAPEUTICS Holding SA (RLFTF.OB).Acer has the rights to develop and commercialize ACER-001 in the U.S., Canada, Brazil, Turkey and Japan while Relief has retained rights to the drug for the rest of the world.ACER closed Friday’s trading at $3.72, down 10.36%.