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DewDiligence

06/21/22 2:20 PM

#242900 RE: 57_2001 #238055

ACER/RLFTF receive FDA CRL:

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

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.”