FDA Determination Letter on ESSENCE Protocol Change

Jett Foundation is very pleased to announce, this Friday, the FDA revised previous protocol for Double-Blind, Placebo-Controlled Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy (ESSENCE). 

This revision allows for a 'totally implantable central venous access device (TICVAD)' to be accessible to patients undergoing studies. 

This is a huge step for the Duchenne Community and Jett Foundation is very grateful for this moment. We would like to thank everyone who made this possible, especially the Bullers' family and those who testified during the Open Public Hearing for all their efforts. 

To read the full FDA Determination Letter, please click here