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Ezutromid: Commercialisation Strategy Summit outlined in August 2016 its strategy for the future development of ezutromid. The Company plans to conduct a randomised, placebo controlled trial designed with the potential to support accelerated and conditional regulatory approvals in the United States and Europe respectively. Assuming positive interim data from PhaseOut DMD, it is anticipated that this trial would start in the second half of 2017, with data available for potential regulatory filings in 2019. Summit also expects to conduct a separate confirmatory clinical trial designed to support full product approvals in major territories. Development of Biomarkers As highlighted, a key endpoint in the PhaseOut DMD trial is measurement of utrophin and muscle regeneration biomarkers from muscle http://madeveoon.journalnewsnet.com/a-small-business-with-the-talent-of-a-large-firm-operates-from-a-rare-business-niche-relating-to-colleges-and-universities-of-all-types-1 biopsies. Summit, in collaboration with Flagship Biosciences their website Inc., has been developing an automated, digital analysis tool to precisely measure muscle maturity and integrity and utrophin expression in individual fibres, and data from this research were presented at the 21st Congress of the World Muscle Society held in Granada, Spain, in October 2016. This research represents an important step in helping to further our understanding of the potential benefits of utrophin modulator therapies such as ezutromid. Fast Track and Rare Pediatric Disease Designations In September, ezutromid was granted two separate designations by the US FDA in the treatment of DMD: Fast Track and Rare Pediatric Disease. Fast Track designation provides the Company with advantages such as opportunities for more frequent interactions with the FDA during all aspects of development, submission of a New Drug Application (NDA) on a rolling basis, and eligibility for accelerated approval and priority review. Rare Pediatric Disease designation could qualify Summit for a Priority Review Voucher upon the approval of ezutromid, which could be used for a subsequent marketing application or sold or transferred an unlimited number of times (although only used once).
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