Medivation, Inc. Q1 2008 Earnings Call Transcript

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2008-05-23 12:02:10.0

Tags: Medivation Inc.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) We will take our first question from Michael Yee of RBC Capital Markets.

Michael Yee – RBC Capital Markets

Great. Thanks. Congratulations on the products so far, David. Couple of questions. Just so we have our expectations in reality, what exactly – what type of data are we going to get at ASCO? Are we going to have the 60 milligram cohort followed out a number of months? Are we going to get the second and third cohorts reported out as well?

David Hung

Obviously, under the embargo rules of ASCO, we aren't allowed to disclose the details of the presentation and advancement of the meeting. We will be presenting more data. As we said, we've gone – dosed higher and more cohorts and at AACR, we only presented PSA data and the little imaging results that we saw in the FDG-PET and FDHT studies. So, we will be presenting more data but I'm really not at liberty to go into a lot more detail about what exactly that will be.

Michael YeeRBC Capital Markets

Okay. On the Huntington's program, you've been saying you're going to complete in Q2. Do you think the actual release – the press release may fall into the third quarter's of what is possible?

David Hung

Yes, it is possible. We will release the results very shortly after we finish scrubbing all the data and going through the data analysis which will happen in the second quarter.

Michael YeeRBC Capital Markets

But the release can actually fall in the third quarter?

David Hung

Yes.

Michael YeeRBC Capital Markets

Okay and then last question, in terms of your 33% to 50% enrollment sites in the U.S. being – as you call that significant, do you have written or confirmed approval from the FDA that would fall under significant?

David Hung

I'll forward that question to Lynn.

Lynn Seely

As you know, the FDA will not decide that until the end of the study and they're actually looking at the data, but we do believe this represents the significant effort that they are looking for.

Michael YeeRBC Capital Markets

Okay, great. Thanks guys.

Operator

Next we'll go to Ian Sanderson from Cowen and Company.

Ian SandersonCowen and Co.

Yes. Thank you for taking the question. On the Alzheimer’s Phase III, have you disclosed the range of NMSC [ph] scores that are going to be use as enrollment criteria?

 

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