NeuroSearch has received preliminary feedback from the FDA regarding the development programme for Huntexil® in the treatment of Huntington's disease. Based on the preliminary feedback, new confirmatory clinical data to support an NDA submission in the US will be required NeuroSearch will await confirmation from FDA as well as feedback from EMA, which is expected in Q2 2011, before defining the global development plan and regulatory strategies for Huntexil®
NeuroSearch (NEUR) has completed an End of Phase II meeting with the United States Food and Drug Administration (FDA). Based on the preliminary feedback from the FDA, a US regulatory submission will require additional clinical data to support the effect of Huntexil® in the treatment of Huntington's disease.
A plan for the generation of additional clinical evidence for Huntexil® in Huntington's disease is currently being developed. However, before defining the global development and regulatory strategies, NeuroSearch will await the final meeting minutes from the FDA and feedback from EMA, which is expected in the second quarter of 2011.