We asked Patrik Dahlen, CEO of Neurosearch to reply to questions raised upon the release of the March 23 "Update" (below) on Huntexil® following Neurosearch meeting with the FDA.
Does this change NeuroSearch's commitment to Huntexil® in HD?
PD: No, not at all. NeuroSearch remains committed to bringing Huntexil® to the market
Will NeuroSearch move forward with a new trial?
PD: We have put all available resources together to be able to move forward with the clinical program. We are awaiting feed-back from the European Medicines Agency (EMA), and based on the pooled feed-back from the two agencies, we will make decisions on how and when we best move forward.
Will the trial be in the U.S? Europe? Global?
PD: A future study will likely include patients in North America and in Europe, however, this will become clearer when we know the full picture - including feed-back from EMA.
How long will it take to get the trial underway?
PD: We are currently preparing different strategies depending on the additional Agency feedback expected during Q2 2011 and we will announce a new strategy after this including timelines for a new clinical study.
We will provide more information about Huntexil clinical trial plans as soon as they are developed.®