A Medical Device Daily
Northstar Neuroscience (Seattle, Washington), a developer of therapies for neurological diseases and disorders, reported an updated timeline related to data analysis of its EVEREST pivotal trial for stroke motor recovery and its planned regulatory submission to the FDA.
Northstar said that after recent communication with the FDA, it now expects to unblind EVEREST data and report four-week primary endpoint results in January, and to submit its premarket application, including 24-week secondary endpoint data and other outcome measures, early in 2Q08.
Based on that communication, the company said it intends to include statistical analysis of safety and efficacy results through 24 weeks in its PMA. Additionally, as directed by the FDA, Northstar will remain blinded to all EVEREST efficacy results until sufficient 24-week data for the PMA submission has been collected.
Northstar previously had said it wanted to submit the PMA by the end of 2007, based on statistical analysis of the four-week primary endpoint EVEREST data, and provide 24-week and other secondary outcome measure analyses as an amendment to the PMA in 2Q08.
John Bowers, president/CEO of Northstar, said, “While we are disappointed that we will be unable to unblind and share the primary endpoint data for [EVEREST] before the end of this year, we recognize the importance of working with the FDA and believe our plan enables us to move forward in a timely manner with a comprehensive data set.”