On Friday, April 11, Retrophin received an update from RE-024 clinical investigators that, despite several investigator-sponsored IND filings for RE-024 in the United States, the FDA has been unwilling to grant a clinical trial through this mechanism. The company intends to file a company-sponsored IND in May or June 2014, with a Phase I clinical trial in PKAN patients beginning in June or July 2014. The company continues to support efforts to launch an investigator-sponsored trial outside of the United States. The company said, “While we are disappointed the FDA has been unwilling to grant expedited access to RE-024 for children with a lethal disease, we respect its decision and are motivated by the enthusiastic and brave physicians and patients who desperately want access to this promising molecule. The small delay is frustrating to all of our stakeholders, but we expect the issue will be resolved in the near term and we are taking steps to grow our R&D infrastructure to avoid similar experiences in the future.”