Newron Pharmaceuticals has provided an update following its Type A meeting with the US FDA. The meeting was related to the hold on the enrolment of new patients at US sites as part of the Phase III ENIGMA-TRS 2 trial, evaluating evenamide in treatment resistant schizophrenia. Newron reported that the discussion was constructive, and that the parties covered potential actions towards the resolution of issues that led to the hold. Newron, as agreed with the regulators, plans to propose changes to address remaining concerns. Management is working towards resolving these issues in the near future.
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