23 August 2019 - The idea of the US FDA releasing complete response letters resurfaced this week as Sarepta Therapeutics received a complete response letter but refused to make public any portion of it.

Following a question on transparency at an event Thursday, Sarepta CEO Doug Ingram said that not releasing the text of the complete response letter (CRL) was “a service to the community” and that FDA might not want a confidential letter to be released. “The basis for the CRL is exactly as I've said it," Ingram said.

He also said the company has “to be respectful of the regulatory body…as I imagine the agency assumes it would remain confidential.

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