Try not to stress mate, the European ph2b trial is designed in...

Try not to stress mate, the European ph2b trial is designed in consultation with various relevant bodies and groups.
Multicentre, randomised, double-blind, placebo-controlled study to be conducted in Europe
• Scientific Advice (SA) meetings held with three European regulatory authorities and SA feedback recently received from European Medicines Agency (EMA) on trial design
• EMA feedback reflected advice from national authorities on appropriateness of key trial parameters: dose duration (1 year), safety monitoring plan, trial efficacy endpoints (PUL2.0 Myoset) and potential pivotal status (meaning potential conditional approval following the Phase IIb)
• Next step to submit a Paediatric Investigational Plan (PIP) to the EMA Paediatric Committee (PDCO) and confirm the Phase IIb trial design via PIP application to be submitted at the end of 2020 or in early 2021. Initial PDCO feedback is to be received ahead of submitting the Phase IIb trial application
• Activities commenced for the manufacture of clinical trial supplies of ATL1102 for the trial Clinical supplies to be available in line with the receipt of PDCO feedback and the approval to commence the Phase IIb trial, anticipated in mid 2021 assuming no material changes or delays based on regulatory feedback