huntexil-update-march-2011

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.®