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