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 Phase IIb clinical trial. The Company advised that it was addressing the PDCO information requirements and anticipated finalising the trial design with PDCO later in Q3’CY21, ahead of submitting the clinical trial application for the Phase IIb trial shortly thereafter.
From 4e
As part of its review of the PIP, the Paediatric Committee...
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