Full FDA letter in hand, Solid Bio says it's working to reverse clinical hold on its DMD gene therapy
Faced with skeptical investors and low share prices ever since the FDA slapped a clinical hold on its gene therapy for Duchenne muscular dystrophy, Solid Biosciences put out a note today detailing how it’s addressing the agency’s concerns. The update also came with positive news: If the PhI/II trial resumes, the biotech would be able to test both the high and low doses of the treatment.
In a full clinical hold letter Solid Bio $SLDB received today, the FDA laid out what it would take to resume the trial: an assessment of the underlying causes of the adverse event, the patient’s clinical status and laboratory parameters, as well as any new measures to address patient safety.
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