AVANIR Pharmaceuticals, Inc. F3Q09 (Qtr End 06/30/09) Earnings Call Transcript

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2009-07-30 00:36:10.0

Tags: Patient, Call Transcript, Microsoft Corp., Earnings, ALS, Seeking Alpha, Avanir Pharmaceuticals

Question-and-Answer Session

Operator

(Operator instructions)

Keith Katkin

As we're waiting for our first question, many investors have asked us about our plans for data dissemination from the STAR trial. Obviously, as we mentioned today we are very excited to announce the top line data in August, and we anticipate that the full data set including all primary and secondary endpoints will be presented at an upcoming scientific conference later this year. Any questions, operator?

Operator

You have a question from the line of Phil Tenna [ph].

Phil Tenna

Thanks for taking the question. Congrats on the progress. Just on the – couple of questions understanding that you got ALS and MS patients in the phase III and in the open label. Is there any commentary that can be given or has been given at least in the blinded part as to what percentage of the 282 patients are ALS or MS and also in the open label extension if there is – the proportions of ALS and MS patients had elected to go on?

Keith Katkin

Sure. So, as you may recall Bill the original study design, which was under a special protocol assessment with the FDA called for 270 patients and that was comprised of 180 patients with ALS and 90 patients with MS. So that was part of the original protocol agreement with the FDA and as you also may be aware, we did wind up over enrolling the study by about 21% and in total we ended up with, I believe, 197 patients with ALS and with 129 patients with MS. So we really did a nice job exceeding the original specified FDA targets in both the ALS population and the MS population.

Phil Tenna

Right, so then out of the 282 that completed, you have the breakout of how many were MS and how many were with ALS?

Keith Katkin

We have ensured data specifically in regards to the numbers, and actually I'm not even sure the numbers myself of the top of my head, but the rollover rates, we're happy with the overall rollover rate, which is 90% for all patient population. So with such a high rollover rate, obviously there wasn't lot of patients that fell out of the study between the end of the double line period and the start of the open label. So we are very happy with the size of the database level and the open label from both the ALS and the MS perspective.

 
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    IreneCarl4

    09/16/09 | Report as spam

    RE: AVANIR Pharmaceuticals, Inc. F3Q09 (Qtr End 06/30/09) Earnings Call Transcript

    very informative and important info.

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    2

    IreneCarl4

    09/16/09 | Report as spam

    RE: AVANIR Pharmaceuticals, Inc. F3Q09 (Qtr End 06/30/09) Earnings Call Transcript

    please continue the most helpful and nessary work and more good results.

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