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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 interview medical laboratory assistant of times (although only used once). The Priority Review Voucher programme was extended on 13 December 2016 through the enactment of the 21st Century Cures Act, under which a drug designated as a Rare Pediatric Disease can receive a voucher if approved before 1 October 2022. DMD Community Website On 12 September 2016, Summit launched , an online resource on utrophin and Summit`s utrophin modulator clinical trials, in an effort to broaden the Company`s relationship with the Duchenne community as it advances ezutromid and other utrophin modulators. C. difficile Infection Programme Summit has generated a comprehensive package of data supporting the potential of the novel class antibiotic ridinilazole as a new front-line treatment of infections caused by the bacteria Clostridium difficile. The Phase 2 proof of concept trial called CoDIFy showed ridinilazole outperformed the antibiotic vancomycin, which is the current standard of care. Ridinilazole demonstrated a large numerical reduction in rates of recurrent disease compared to vancomycin with this difference driven by ridinilazole outperforming vancomycin in the preservation of the gut microbiome. Recurrence of CDI, and the failure to subsequently achieve a sustained clinical response after treatment, is a major issue in the management of the disease, as collateral damage to the gut microbiome by antibiotics such as vancomycin leaves patients vulnerable to disease recurrence. Phase 3 preparations are ongoing as the Company continues to explore options to support the future development of ridinilazole with a view to maximising the potential commercial value of this antibiotic. Summit`s preference remains finding a third party collaborator although the Company continues to actively explore other potential options, including funding from government and non-profit organisations.

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Youll receive free e-mail news updates each time a new story is published. Youre all set! By Bethonie Butler December 18 at 4:07 PM Follow @bethoniebutler (All times Eastern) Antiques Roadshow (WETA at 8) The show looks back on treasured appraisals from the past 20 years. Man With a Plan (CBS at 9) Adam does his best to guide his eldest daughter through a momentous occasion. 2 Broke Girls (CBS at 9:30) Han and Caroline help Max try his response to get Randy back. This involves a road trip to Los Angeles. StarTalk (National Geographic Channel at 11) Neil deGrasse Tyson interviews William Shatner. Premiere The Wall (NBC at 10) Pairs compete to win more than $12million in cash prizes in this game show, produced by LeBron James and hosted by the ubiquitous Chris Hardwick. This is a sneak preview the official premiere is slated for Jan. 3. Specials First Lady Michelle Obama Says Farewell to The White House: An Oprah Winfrey Special (CBS at 8) find more info In an interview taped at The White House, Michelle Obama reflects on the past eight years, her legacy as first lady and her plans for the future.

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