Thanks Samuel.
Harmonisation still on table; key focus.
Use of the data from the EU Phase IIb/III trial to support a US market approval is a key focus of ANP.
This approach clearly has time and cost benefits, but also allows for an expedited development pathway potentially supporting faster access to efficacious drugs for longsuffering DMD patients. The FDA’s willingness to engage on this harmonisation prospect, with interactions and discussions planned over CY22 suggests they are open to this prospect.
We expect this to be a key priority for ANP management throughout CY22, once their EU study is underway and recruiting
Chart, page-4646
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