ARYx Therapeutics, Inc. Q3 2008 Earnings Call Transcript

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2008-11-12 11:52:10.0

Tags: FDA, Call Transcript, Earnings, Jefferies & Co., Aryx Therapeutics Inc., Federal Government, Government, Seeking Alpha, FDA, Call Transcript, Earnings, Jefferies & Co., Aryx Therapeutics Inc., Federal Government, Government, Seeking Alpha

Question-and-Answer Session

Operator

Thank you Dr. Goddard. Ladies and gentlemen, our question and answer session is conducted electronically (Operator instructions) We will go first today to Adam Walsh of Jefferies & Co.

Adam WalshJefferies & Co

Hi Paul and John, thanks for taking my question. How are you?

Paul Goddard

Good morning I am doing fine. Hi Adam.

Adam WalshJefferies & Co

So I have got a few, I guess the first one here is Paul you mentioned you don’t want Big Pharma to have the upper hand in their discussions but I am curious as to why now that you have financing deal in place, why you would continue to consider a pre-dated deal for 5923 since it seems as though with the cash on hand you might be able to generate the data by mid next year and be in a better position to negotiate with Pharma.

Paul Goddard

Adam that is a good question and if you recall what we said on our previous quarterly update that we were in active discussions to establish whether or not we could complete a deal on 5923 by the end of the year and that process basically is playing itself out at the moment. And I think the point to be made both to people listening on this call and also to potential partners is really to John’s point which is we are not going to accept any terms where we would not consider it to be appropriate to the value of the product and that really assumes a positive outcome of the ongoing Phase 3 study. So, we are willing to back away very quickly now from any half-baked set of terms for this product.

John Varian

With that said, there is one other thing, one of the reasons we thought about this seriously is having a partner in place sooner can accelerate the time to market for the product. So that is somewhat of an offsetting factor and one of the reasons that we continue to consider doing a pre-dated deal but again importantly, you hit the nail on the head, by doing this financing we have the choice of either doing a pre-dated deal or waiting for the data and trying to capture the value that way.

Adam WalshJefferies & Co

Great. My second one here is also on 5923, you mentioned in your release here that based on recent interactions with the FDA you believe that this Phase 2/3 could be positioned as a pivotal, and I guess my question there is the FDA has been obviously an extremely tough customer here as development stage companies try to bring drugs forward, my question on that is can you elaborate a little bit on these interactions and how confident you feel that the interactions we are having today are actually indicative of what the FDA’s ultimate position might be on the status of this trial?

 

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