Acer, Relief get FDA Complete Response for urea cycle disorder med

 Citing the need to inspect a third-party contract packaging manufacturer, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)

The FDA has not raised any approvability concerns related to the efficacy, safety or
pharmacokinetics of ACER-001

https://finance.yahoo.com/news/acer-therapeutics-relief-therapeutics-announce-123000980.html