Arrowhead Research Corporation (ARWR) Q4 2014 Results Earnings Call Transcript

Bruce Given: Yeah, Alethia as you know it’s always unknown, we like the data package, we think it’s very solid and very complete, but one variable until the first time you submit to the FDA, is the first time you submit and it’s hard really for me to gauge that risk. We feel like the clinical data is very strong. We feel like the tox data is good and everything else, but ultimately they – as we always say, we submit, they review, they decide. And that’s always the case.

Alethia Young – Analyst, Deutsche Bank

And, what are the timelines for submitting again? Or have you kind of characterized it more specifically that?

Bruce Given: Before the end of the year.

Alethia Young – Analyst, Deutsche Bank

Okay. And you guys don’t have any sort of fast-track or anything?

Bruce Given: Not at this point. No, we haven’t asked for it either, haven’t asked and haven’t received.

Christopher Anzalone: And that’s a really good question Alethia. We thought about that and we have spent an awful lot of time working on our manufacturing and making sure that we’re able to scale this up quickly, should we get lucky and see functional cures early because I think that if we were to see that, I think regulatory agencies will get excited quickly. And we can move I think fairly quickly towards into Phase 3, and we want to make sure that our manufacturing is not going to slow us down for that. So, hopefully we can explore that possibility in the future.

Operator: Thank you. We’re showing no one else in the queue at this time. I’ll turn the conference back over to Mr. Chris Anzalone, for closing remarks.

Christopher Anzalone: Thank you, everyone. And I wish you all happy Thanksgiving and a happy holiday season.

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Operator: Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program. You may all disconnect and have a wonderful day.

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