Question-and-Answer Session
Operator
(Operator Instructions) We’ll take our first question from Kim Lee with Pacific Growth Equities.
Kim Lee – Pacific Growth Equities
Good afternoon. Thanks for taking my questions. The first couple of questions have to do with the Dimebon program. Just wanted to get a clarification, will the monitored severe disease be an add-on indication or will you wait to sell your First NDA in mild patients to include the severe population?
Darryl Messinger
Well, I think Kim, what we really need to do is to have a broad program so that we can maximize the potential of Dimebon and really take full advantage of all of its commercial possibilities. So at this point and time, we’re intending to file together.
Kim Lee – Pacific Growth Equities
Additional Phase 3 trials do you expect to run and what do you foresee as the trial designs for these trials?
Darryl Messinger
At this point in time, we haven’t given details on the specific designs but I think that what we can say is we – and what we have said in the information David just told you is that we will be running an add-on therapy 12-month study to really look at the benefit of Dimebon on top of cholinesterase inhibitor and also, Phase 3 (inaudible 00:18:52) moderate to severe.
Operator
Han Li with Stanford Group.
Hanzhong Li – Stanford Group Company
Thank you. Good afternoon to everyone. Question for Lynn, on the combination, Aricept combination study which you say is safe while tolerated, can you remind us how many patients in the study and what’s the control – the placebo arm and when do we see the efficacy result from this study?
Lynn Seely
Well, this was a study, was a placebo-controlled safety study with a 1-month treatment duration. We did look at the safety profile of Dimebon in combination with donepezil and we found that the combination was very well-tolerated. We didn’t have any patients discontinue the trial due to adverse events or safety problems and so it was very well-tolerated.
Hanzhong Li – Stanford Group Company
Will the patients stay on the drug in extension study of this trial or –
Lynn Seely
We have offered patients the opportunity to continue in an open label extension so there won’t be any placebo-controlled efficacy data.
Hanzhong Li – Stanford Group Company
Okay, how many patients in this study, may I ask?
- To read the full transcript on Seeking Alpha, click here »
