”Antisense Therapeutics reported on Friday 30 September (2021), that it had received a draft opinion recommending agreement with the company’s Paediatric Investigation Plan (PIP) for the development of ATL1102 for Duchenne muscular dystrophy (DMD) from the Paediatric Committee (PDCO) for the European Medicines Agency (EMA). This is not a final decision, but we understand it is very unusual for the EMA not to adopt a recommended PIP. A PIP must be adopted by the EMA before a medicine can be approved for use in children in EU Member States. The receipt of the of the draft opinion by Antisense is a significant positive for the company.”
The above was from Corporate Connect
With due Respect $$ man:
Ema 120 days discussion completed PDCO recommended
FOR ADOPTION
Itsagas: 100% confident “Done and dusted”&$$$$
Where others have failed will Atl1102 succeed ?, page-729
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