$SLDB FDA Lifts Clinical Hold case study
Solid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial
As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.
“We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”
finance.yahoo.com/news/solid-biosciences-announces-fda-lifts-113000250.html
As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.
“We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”
finance.yahoo.com/news/solid-biosciences-announces-fda-lifts-113000250.html
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