AVANIR Pharmaceuticals F2Q09 (Qtr End 3/31/09) Earnings Call Transcript

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2009-05-07 12:25:31.0

Tags: Randall, Call Transcript, Earnings, Endpoint, Question, Avanir Pharmaceuticals, Seeking Alpha

Question-and-Answer Session

Operator

(Operator Instructions).

Keith Katkin

Thank you, operator. While we're waiting for any questions, I'd like to let everyone know that we'll be presenting at the Deutsche Bank 34th annual healthcare conference on May 19. The live presentation will be webcast and available for replay on our website for 30 days if you are unable to listen to the live presentation.

Operator, do we have any questions at this time?

Operator

Yes, several questions from the line of Robin Davison with Edison Investment.

Robin Davison - Edison Investment

Hi, hello guys. I was looking at the second quarter, actually Zenvia was as the return of the Special Protocol Assessment, which if any of the secondary endpoints, do you have to see -- significant to meet the requirement quality absolutely to the primary end point? And then the other question is really, Keith whether there's probably something you guided from the cash utilization in '09. I wonder whether I am thinking it particularly changed or pushed out to cause that sort of -- in terms of dollar saving?

Keith Katkin

Thanks Robin. I'll answer the question about the cash burn and then I'll turn it over to over to Dr. Randall Kaye to answer the questions about the Special Protocol Assessment.

In regards to the cash burn, we have not delayed or pushed out any programs. We have really focused on examining every cost that is non-essential to the Zenvia PBA clinical program. And quite frankly we've taken advantage of somewhat of the downturn in the economy. And we've asked all of our vendors to do their fair share in helping us manage our cash. And we're able to secure discounts from almost the majority of all our vendors. So a good prudent management plus reaching out in these economic times and asking for discounts that would allow us to reduce our overall expenses. And that -- now I'll now turn over to Randall for -- to answer the question about that Special Protocol Assessment.

Randall Kaye, M.D.

Sure. Robin I think your question was about what was specified with the agency in the Special Protocol Assessment for the statistical analysis plan, what's required is...

Robin Davison - Edison Investment

Exactly yes.

Randall Kaye, M.D.

Yeah. So what's required is demonstration of the primary analysis of the primary endpoints, so that's purely changing episode count of the 3010 formulations versus placebo. And we certainly pre-specified all our additional analysis both the primary and secondary as well as some exploratory endpoints, but the requirement for the SPA is succeeding the primary endpoint.

 

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