Carl Byrnes: Excellent, thanks so much.
Jim Brown: Sure.
Operator: Thank you. Our next question is coming from Ed Arce with H.C. Wainwright. Please proceed with your question.
Thomas Yip: Hi, good afternoon everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So first, just to clarify, that the communications that you’re describing with the FDA, is this the NFA2 meeting and also assuming a path for [this identify] (ph) from these meetings? Can you just talk about a rough timeline to [figure out] (ph) specifically how many months for the trial to begin and also how long the study will be from start to finish?
Jim Brown: Yeah, I wouldn’t want to comment on that until we have finished our communication with them around the protocol, but certainly what we’re discussing is a path forward for our Phase 3 to obtain approval for this drug, and that much you can take home. But beyond that, I would wait till we finish the communications.
Thomas Yip: Understood. Then perhaps, as you pointed out, you’re in communications with the Agency. Can you share some preliminary thoughts just internally? What will you consider to be key elements of this pivotal study, specifically some key endpoints that you will focus on and also how large the study will be.
Jim Brown: Yeah, I would want to wait until we finish with our dialogue with them, but it’ll be similar, I think, to what we have seen. I mean, if you look at the trial that we just had, we looked at the 232 patients that we dosed within the United States, and we saw this near 60% reduction, statistics of below 0.01, 20% fewer adverse events, those kind of things. So I think we’ve got a good basis to build from as we look for a Phase 3 design, but we’ll wait till it’s done before we talk about it. But I think if you consider that trial, you’re [not going] (ph) to be in the ballpark.
Thomas Yip: Understood, perhaps one more question from us, this one regarding the ALZET agreement with Charles River Labs. Just wondering if you can share some financials [indiscernible] licensing is key there and how the private share structures between the two companies.
Jim Brown: Yeah, I don’t know how much we would share on the financials, but we have Keith Lui on the line, and Keith is our Head of Commercial and Business Development, and ALZET reports into him, so I’ll let him kind of speak to the relationship with Charles River and the excitement that we have for being able to work with them. So, Keith, please.
Keith Lui: Yeah, thanks, Jim. I don’t think we’ve discussed the financials in particular, but this is the first ever sales and marketing collaboration for the ALZET product line that we’ve had in the US and Canada. So we are certainly excited about that and with that important collaboration with as quality of an organization as Charles River that is a well-known organization worldwide and partnering particularly with their research models and services group. They have a pretty robust sales force out there. It’s the presence that we’ve never had in US or Canada for the ALZET product line. So we are really looking forward to the partnership which kicked off just on January 1st. Sales force is trained and I think we can report some of the positive findings from that relationship in subsequent calls.
Thomas Yip: Got it. Thank you again for taking our questions and we look forward to the conclusion of your discussions with the FDA for larsucosterol.
Jim Brown: Absolutely, as do we. Thank you so much.
Operator: Thank you. It appears we have no additional questions at this time. So I would like to pass the floor back over to Dr. Brown for any additional closing remarks.
Jim Brown: With that, I just want to thank you for your time. And as always, if you have additional questions, please reach out to us, and we look forward to catching up. Thank you all, and take care.
Operator: Ladies and gentlemen, this does conclude today’s teleconference. Once again, we thank you for your participation and you may disconnect your lines at this time.
