FDA Rejects Acer Therapeutics - Relief Therapeutics' Urea Cycle Disorder Candidate - Relief Therapeutics (OTC:RLFTF)

The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc ACER and its collaboration partner, Relief Therapeutics Holding SA's 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.

FDA Rejects Acer Therapeutics - Relief Therapeutics' Urea Cycle Disorder Candidate