Sarepta Rare Disease Advisory Panel Meeting today, page-4

Perhaps the disappointment of the independent advisory panel's negative decision of SRPT's DMD drug this week will be lessened by the FDA's recommendation for study in the US  and UK by a different sponsor (Summit Therapeutics) with a different approach, and hopefully better trial design than SRPT's:

http://hsprod.investis.com/servlet/HsPublic?context=ir.access&ir_option=RNS_NEWS&ir_client_id=4747&item=2442799156822016

SUMMIT'S IND CLEARED BY FDA ALLOWING EXPANSION OF PhaseOut DMD, A PHASE 2 CLINICAL TRIAL OF EZUTROMID (SMT C1100), INTO THE US

Enrolment of Patients with DMD in the US Expected to Start 3Q 2016

Utrophin Modulation Offers Differentiated Approach in DMD

Oxford, UK 26 April 2016 - Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and Clostridium difficile infection, announces that the US Food and Drug Administration has cleared the Company's investigational new drug ('IND') application to expand the Phase 2 proof of concept clinical trial called PhaseOut DMD to trial sites in the US. PhaseOut DMD will evaluate the Company's lead utrophin modulator, ezutromid (formerly known as SMT C1100), in patients with DMD at sites in the UK and the US.

In contrast to many current therapeutic approaches to DMD, utrophin modulation has the potential to treat all boys and young men with DMD, regardless of their underlying dystrophin gene mutation.

"The IND clearance for PhaseOut DMD paves the way to expand PhaseOut DMD into the US and will provide access to a wider network of leading physicians in DMD as we seek to improve the lives of patients and families living with this devastating disease," said Ralf Rosskamp, MD, Chief Medical Officer of Summit. "PhaseOut DMD aims to show the potential benefits of ezutromid as a disease modifying approach for DMD for the first time in patients, and this approach could ultimately benefit the entire DMD patient population."