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Re: OFP post# 163532

Thursday, 08/23/2018 12:53:35 PM

Thursday, August 23, 2018 12:53:35 PM

Post# of 463986
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.
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