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Re: gambler2075 post# 91750

Tuesday, 12/01/2015 2:49:48 PM

Tuesday, December 01, 2015 2:49:48 PM

Post# of 97239
$CBAY I also like the fact that probably partnership for P3 is coming next year (at least that is their goal) and they don't feel deterred by the Lesinurad adcom:

http://seekingalpha.com/article/3681976-cymabay-therapeutics-cbay-ceo-hal-van-wart-on-q3-2015-results-earnings-call-transcript


Mara Goldstein - Cantor Fitzgerald
Hello, thanks very much for taking the question. I have two and the first is related to arhalofenate and I’m just curious more than anything around some of the takeaways from the Lesinurad FDA Adcom meeting and how that informs anything for potential partnership in terms of what partners may have had notions about before them and about basically not in the end of Phase 2 meeting. And then, I just wanted to ask on MBX-8025. On the secondary endpoint, I know you just said how that the additional five patients could be meaningful in terms of looking at the primary endpoint. And I’m curious as to how proportional effects might be on some of those secondary endpoints basically as it relates to positive indicators of cholesterol and if you might be able to comment on that?

Hal Van Wart - President & CEO
Sure. Well let me take the first question, first. We listened with great interest into the Lesinurad Arthritis Advisory Committee meeting that was held a week or two ago and we would of course prefer not to comment on Lesinurad itself but there were a tremendous number of things that were very important for us to hear and learn about.

First of all, we were very clear from the discussion at the committee that both the committee members as well as the FDA are looking for a safe effective urate drug to be used in combination with XL inhibitors. And it's also clear that both the committee and the FDA were looking for clinical benefits such as flare reduction, focus resolution in addition to improvement in the surrogate markers serum uric acid.

Now that made us all feel very good because this almost matches identically arhalofenate profile where we're able to get patients not only to the uric acid goal but do it in a way that reduces their flare way which is very clinically meaningful. And we do it so far with 1,100 patients of beta with no signal with regard to renal safety. So we came away feeling pretty good that we are synchronized with the medical community with regards to the unmet needs in gout and that arhalofenate truly has something to offer.

Now we think of course that will play through very well to the pharma companies that may have well listened into that presentation or can access the documents and confirm to themselves that the advisory committee probably would have liked arhalofenate.

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