Posted by Michael Wonder on 17 Oct 2022
Minerva Neurosciences receives refusal to file letter from FDA for its new drug application for roluperidone for the treatment of negative symptoms in schizophrenia
17 October 2022 - Minerva Neurosciences today announced that the company has received a refusal to file letter from the US FDA regarding the company’s new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
