FYI
"European Medicines Agency Paediatric Investigation Plan (PIP) feedback received for ATL1102 in DMD As part of its review of the PIP, the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) provided feedback outlining additional information requirements on the Company’s planned Phase IIb clinical trial in non-ambulant DMD boys. ANP is addressing the PDCO information requirements and anticipates finalising the trial design with PDCO later in Q3’CY21, ahead of submitting the clinical trial application shortly thereafter for the Phase IIb trial of ATL1102 in non-ambulant DMD patients to be conducted in Europe."
Cheers
.
Anp at world muscle society, page-42
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