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Investor2014

08/23/18 12:53 PM

#163533 RE: OFP #163532

In the case of the Sarepta DMD study I do not believe RWE had been baked into the protocol.

Janet Woodcock was at pains to hint to the review board that the RWE presented by patients, parents, advocacy group and Sarepta should carry weight.

Eventually RWE won the day even if it wasn't planned.