» Orexigen Therapeutics CEO Discusses Q2 2012 Results - Earnings Call Transcript
» Cutera Management Discusses Q2 2012 Results - Earnings Call Transcript
Factors that could cause actual results to differ are discussed from time to time in the company’s filings with the SEC, including our annual report on Form 10-K, and our reports on Form 10-Q and 8-K. These documents are available on the investor relations section of our website, and we encourage you to review the materials. The company has no obligation to publicly update or revise these forward-looking statements to reflect the events or circumstances after the date they are made.Participating on today’s call are Eamonn Hobbs, President and Chief Executive Officer; and Graham Miao, Executive Vice President and Chief Financial Officer. Following their opening remarks, we will open the call to questions from analysts and institutional investors. To maximize the time allowed for Q&A, please ask two questions and if you have additional questions please requeue to ask those additional questions. In advance, we thank you for your cooperation. And now I would like to turn the call over to Mr. Hobbs. Eamonn Hobbs Thanks Doug, and good morning everyone. Since we last spoke with you in May, Delcath has made important progress on a number of fronts. During our second quarter and in recent weeks, we made substantial progress towards completion of our new drug application, and are on schedule for submission to the FDA this month, received FDA acceptance of the IND Amendments for use of our Generation 2 filter in our US Expanded Access Program, expanded the total number of leading European cancer centers participating in our CHEMOSAT launch program to 13, recognized our first-ever commercial revenues, raised approximately $21 million in net proceeds through a follow on offering, and strengthened our board of directors with the appointment of two pharma industry veterans. On our call this morning, I will provide some detail on these operational highlights and then Graham will review our financial results. Then we will be happy to take questions. I will begin with an update on our NDA submission. I am pleased to report that as we reported at our annual meeting we resolved all outstanding safety queries and locked the database on May 25.
After data lock, we conducted statistical analysis and began finalizing the various modules that comprise our NDA submission. Our NDA is based on the efficacy and safety datas generated from the use of our Generation 1 system in our clinical trial. At the same time, after consultation with a variety of experts and the FDA, we have agreed to include the addition of the Generation 2 filter in the NDA as a technical change as part of the CMC or Chemistry, Manufacturing, and Control module.We believe it is in the best interests of US patients to accelerate availability of Generation 2, and that this approach represents the fastest regulatory review path for the Generation 2 system. At this juncture, many components of the NDA have been completed and sent to an outside vendor for final electronic publishing, and we expect the remaining few items to be sent to the outside vendor for final electronic publishing this week. So we remain on track to file with the FDA as planned mid-month. We will be requesting priority review for our NDA at the time of filing. Assuming the NDA is accepted and that priority review is granted, our expected PDUFA date would be in February of next year. We’re pleased by the FDA’s acceptance of our amendments to our Investigational New Drug Application or IND, and our Expanded Access Program to include the Generation 2 filter. These amendments permit physicians at select US cancer centers to use the Generation 2 system in Expanded Access and compassionate use cases after they obtain institutional review board or IRB approval. Compassionate use cases with the Generation 2 filter have already occurred in the US, and we expect that procedures under the EAP will begin at up to 6 centers this fall. The amendments also permit use of the Generation 2 system in the clinical trials we have planned as part of our clinical development program, and it is our intention to use Generation 2 in all upcoming prospective clinical trials. Read the rest of this transcript for free on seekingalpha.com