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BRIEF-Intra-Cellular Therapies announces positive regulatory update on schizophrenia program
2017年8月23日 / 中午12点21分 / 1 个月前

BRIEF-Intra-Cellular Therapies announces positive regulatory update on schizophrenia program

Aug 23 (Reuters) - Intra-cellular Therapies Inc

* Intra-Cellular Therapies announces positive regulatory update on schizophrenia program

* Intra-Cellular Therapies Inc- ‍U.S. FDA has informed company that FDA has completed its review of company’s responses to requests from FDA​

* Intra-Cellular Therapies-‍requests from FDA relate to information regarding some findings in nonclinical toxicology studies of lumateperone in animals

* Intra-Cellular Therapies-‍FDA agrees that co presented adequate data to support position metabolic pathway in animal species is distinctive from humans​

* Intra-Cellular Therapies-‍moving forward with long-term safety study of lumateperone, intends to submit NDA for treatment of schizophrenia by mid-2018​ Source text for Eikon: Further company coverage:

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