Question-and-Answer Session
Operator
(Operator instructions). We will go first to Kim Lee [ph] with Wedbush Morgan.
Kim Lee – Wedbush Morgan
Good afternoon. Thanks for taking my questions. I have a couple of questions here. The first is what are the trial designs for the two additional Phase 3 Dimebon trials in moderate to severe patients?
David Hung
Lynn?
Lynn Seely
Sure. Thanks, Kim. We are planning two trials. One of them will have 500 patients; the other will have 600 patients. One will be looking at patients on already taking memantine and the other will be looking at patients taking Donepezil.
Kim Lee – Wedbush Morgan
Okay, great. And this is – so this is already background therapy it's Dimebon plus or versus placebo they all have background therapy.
Lynn Seely
That's correct.
Kim Lee – Wedbush Morgan
Okay. And now will these two trials also be part of your registration trial if you decide to register early for or apply for early marketing approval in 2011?
Lynn Seely
So we along with Pfizer are putting ourselves in position to be able to file in an earlier to file strategy if we choose to do so with a connection study and the already completed Lancet study along with the safety study that we just described. These moderate to severe studies will be part of the full file package that we discussed to be filed in 2011.
Kim Lee – Wedbush Morgan
Okay, great. And on financial modeling question here. Will the $65 million in revenue from Pfizer, from the Pfizer collaboration be recognized directly as licensing revenue on the top line?
Patrick Machado
It will be recognized as collaboration revenue, Kim, on the top line?
Kim Lee – Wedbush Morgan
Okay. Thanks a lot.
Operator
We will go next to Michael Yee with RBC Capital Markets.
Michael Yee – RBC Capital Markets
Hi, great, thanks. Dave, a couple of questions David. In regards to the 750 patient study that safety study you're talking about, is this a six month, is a one year study? What are the primary and secondary end points and are they stratified by the background drug in regards to thepharided [ph] background anti-dementia drugs?
Lynn Seely
This has a two cohort design; the first cohort of patients will be followed for six months. The second cohort of patients will be followed for three months again in order to allow us to complete the study in an expeditious fashion. These patients will be allowed a variety of background treatments and it is purely a safety and tolerability study in terms of end point.
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