Chelsea Therapeutics International Ltd. Q3 2009 Earnings Call Transcript

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2009-11-02 17:27:07.0

Tags: FDA, Call Transcript, Earnings, EMEA, Chelsea Therapeutics International Ltd., Anupam, Federal Government, Business Structures, Government, Finance, Seeking Alpha

Question-and-Answer Session

Operator

(Operator instructions) And our first question will come from Brian Abrahams with Oppenheimer.

Anupam Oppenheimer

Hi, guys. This is Anupam [ph] in for Brian. Quick question, is there anything specific we should be looking for from Dr. Kaufmann's presentation at AF [ph] in a couple of weeks?

Dr. Simon Pedder

We have given the kind of 10,000 fee [ph] of the data. I think that Dr. Kaufmann who gave a little bit more detail but I don’t think there is any surprises – we’ve talked in pretty much detail about the primary and secondaries and I think Dr. Kaufmann's presentation is going to basically give a little bit more flavor on that, but I wouldn't expect, the story doesn’t change, still the same ending.

Anupam Oppenheimer

Okay. We’ve heard a lot about your plan for – with the FDA, do you had any discussions with the EMEA regarding the passport for Droxidopa?

Dr. Simon Pedder

We have not had any discussions with the EMEA since the 302 results, no.

Anupam Oppenheimer

Okay. I guess, those are all my questions so far.

Dr. Simon Pedder

Well, thanks a lot.

Anupam Oppenheimer

Jump back in the queue.

Operator

We’ll move on Liana Moussatos with Wedbush

Liana MoussatosWedbush

Thank you. In this, are you planning to announce the results of the FDA meeting in December or we – and so you announced the top line data from 301 trial in January?

Dr. Simon Pedder

We will probably get back to on the outcome of the FDA meeting in early December.

Liana MoussatosWedbush

Okay. And what’s the status, how will you characterize the status of the antifolate partnership? You mentioned the CH-4051 Phase 2 design, you announced that by year end, any kind of indication about a partnership?

Dr. Simon Pedder

Well, we had the benefit of meeting with lots of people at the ACR meeting in Philadelphia just a couple of weeks ago. That was a great for us not just having a chance to talk to partners, but also talk to a number of key opinion leaders in the field. And I think that’s what the large (inaudible) is finalizing, getting closing to finalizing what we’re going to do in our Phase 2. But we’ve always said we appreciate the fact that 4051 has just completed Phase 1, but we’ve always said that we look for Phase 2 type deal. And, if that means taking the drug ahead ourselves and doing the study the people to want to see them, we'll go ahead and do it.

 

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