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Delcath Systems 's CEO Discusses Q2 2012 Results - Earnings Call Transcript

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.

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