Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer

It’s never fun to receive a CRL, but perhaps even less so when the rejection has to do with manufacturing rather than the drug.

Rare disease player Acer, along with Geneva-based partner Relief Therapeutics, unveiled Tuesday that the FDA had issued the two a CRL for ACER-001, a drug candidate to treat urea cycle disorders.