Richard Pascoe
Thank you, Matt. Good afternoon, and thank you all for joining us on the call today. In the third quarter of this year, we continued to execute on our key corporate objectives by filing the U.S. Vitaros new drug application for NDA, resubmission with the Food and Drug Administration and improving our financial outlook resulting in a balance sheet as expected to fund our current operating plan through the end of 2018.
As a reminder, the FDA acknowledged receipt of our NDA resubmission and confirmed that our PDUFA goal date is February 17, 2018. Since the acceptance of our submission, we have continued to interact with members of the review team at the FDA regarding our NDA on an as-needed basis in an effort to support their review, and we remain confident that we have addressed the deficiencies and the complete response and further strengthen the Vitaros risk-benefit profile with additional efficacy analysis and safety data.
Importantly, we continued to look beyond the Vitaros approval decision to prepare Vitaros for commercialization. To date, we have taken steps to further secure the Vitaros U.S. supply chain. We have completed an extensive market research effort to include both qualitative and quantitative research with patients, providers and payers to better understand the Vitaros opportunity and the broader U.S. ED category. We have begun work on pricing and distribution strategies to maximize the products revenue and access to patients, and we are finalizing the positioning and physician targeting for Vitaros that we believe will enable Vitaros to be successful in the U.S. We further believe that in doing this preparatory work, we have enabled - we will enable Allergan to make an informed decision on commercialization upon approval as well as aid Allergan or another party to successfully launch Vitaros in the U.S. following its approval.
