Neurosearch A/S Shares Plunge as FDA Wants More Data
Published: Mar 24, 2011
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.
Patrik Dahlen CEO