- The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc (NASDAQ:ACER) and its collaboration partner, Relief Therapeutics Holding SA's (OTC:RLFTF) ACER-001 (sodium phenylbutyrate), for urea cycle disorders (UCDs).
- The CRL states: "[The FDA's] field investigator could not complete inspection of [Acer's third-party contract packaging manufacturer] because the facility was not ready for inspection. Satisfactory inspection is required before [the NDA] may be approved. Please notify us in writing when this facility is ready for inspection."
- The FDA did not cite any other issues in the CRL about the NDA nor request that any additional clinical or pharmacokinetic studies are conducted before FDA approval.
- The FDA requested additional nonclinical information to be provided in the resubmission of the application.
- Acer is actively collaborating with its third-party contract packaging manufacturer.
- It intends to resubmit the updated application for ACER-001 in early-to-mid Q3 2022.
- Price Action: ACER shares are down 11.40% at $1.56, and RLFTF shares are down 16.53% at $0.025 during the market session on the last check Tuesday.
