Relief Therapeutics Holding AG (RLFTF)

[PennyWorld]

So, we should see ACER resubmit the NDA sometime in July or August. Other than the routine FDA site inspection, no other approval issue was cited in the CRL which should (no guarantee) allow rapid approval from the FDA. IMO - FDA approval of ACER-001 would be positive news for ACER's holding company ----- RLFTF.

Excerpt.....

The FDA did not cite any other approvability issues in the CRL pertaining to the NDA, nor request any additional clinical or pharmacokinetic studies be conducted prior to FDA approval. The FDA did provide one comment in the CRL (identified as “not an approvability issue”) requesting additional existing nonclinical information to be provided in the resubmission of the NDA.

Acer is actively collaborating with its third-party contract packaging manufacturer and cooperating with the FDA to address the FDA’s comments as soon as reasonably possible and currently intends to resubmit the updated NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs in early-to-mid Q3 2022.

https://www.acertx.com/2022/06/21/acer-therapeutics-and-relief-therapeutics-announce-update-on-u-s-fda-review-of-new-drug-application-nda-for-acer-001/