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AVEO Pharmaceuticals (AVEO)
Q1 2013 Earnings Call
May 02, 2013 4:30 pm ET
David B. Johnston - Chief Financial Officer and Principal Accounting Officer
Tuan Ha-Ngoc - Chief Executive Officer, President and Director
Previous Statements by AVEO
» AVEO Pharmaceuticals' Management Presents at Barclays Global Healthcare Conference (Transcript)
» AVEO Pharmaceuticals' CEO Discusses Q4 2012 Results - Earnings Call Transcript
» AVEO Pharmaceuticals Management Discusses Q3 2012 Results - Earnings Call Transcript
David B. Johnston
Thank you, operator, and thank you, all, for joining us. With me today is Tuan Ha-Ngoc, our President and Chief Executive Officer.
Let me remind everyone that certain matters discussed today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about AVEO's future expectations and plans, clinical development and regulatory timelines and the potential approval and success of our product candidates. These statements involve risks and uncertainties, which are described in the Risk Factor section of our most recent Form 10-K, filed with the SEC and available online at sec.gov.
While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so.
Now before I pass the call over to Tuan, we want to let you know upfront that we will limiting today's call to our prepared remarks, and we will not be holding a question-and-answer session. We acknowledge that you have a lot of questions, to which we do not yet have answers. While the formal review process for the tivozanib remains ongoing, we're going to refrain from conversations with the investment community and members of the media. We believe this is the most appropriate course of action at this time and appreciate your understanding. Now with that, let me pass the call to Tuan.
Thank you, Dave. Good afternoon, everyone, and thank you for joining us. Today the FDA's ODAC met and discussed the data of -- for tivozanib included in our New Drug Application.
We're very disappointed with the outcome and strongly disagree with the views expressed today by members of the Advisory Committee.
Although we recognize that the confounding nature of the crossover will be the important topic for discussion at ODAC, we were dismayed by the sentiments expressed today by members of the panel.
TIVO-1 was designed in collaboration with the key opinion leaders in RCC field, and the primary endpoint of TIVO-1 progression free survival was achieved.
PFS has been the agreed upon primary endpoint approval of all other TKIs in this indication.
There remains a need for new treatment option for patients living with kidney cancer, as you heard during the public comment period. We appreciate the perspective and personal stories shared today by several patients, nurses and patient advocates regarding their first-hand experience with tivozanib and the tangible unmet need in kidney cancer despite the availability of multiple existing treatment options.
On behalf of everyone at AVEO, I would like to thank the patients, their families and the investigators for their participation in our clinical trials.
In addition, we would like to thank the physician experts who joined us today, in particular, Dr. Motzer and Dr. George, who underscored both the unmet need in treating patients with advanced RCC and the promise of tivozanib in this patient population.
I would like to acknowledge the excellent work by AVEO's clinical and regulatory teams in their execution of TIVO-1 in preparing for this ODAC meeting.
As you can imagine, we are evaluating the feedback received today and its implications, and we will not be hosting a Q&A session. Let me finish by restating that we're confident in the efficacy, safety and tolerability of tivozanib in patients with RCC and its promise in other tumor types.
Thank you for joining us this afternoon, and have a good evening.
Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.