Hi Akki - no they have not been granted the ODD mate - the answer is in the Investor presentation issued this morning - BUT I doubt that it won't be long before we see the ODD approval.
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on the company’s submission for Orphan Drug Designation (ODD) for ATL1102 for Duchenne muscular dystrophy § Orphan drug designation in the EU is granted by the European Commission (EC) based on a positive opinion issued by the EMA COMP.
EMA has forwarded the opinion to the EC for its decision on the recommendation. The designation is given to medicinal compounds meant to treat rare conditions that are life threatening or chronically debilitating and where the treatment provides a significant benefit to those affected by the condition or no satisfactory treatment is available § Orphan drug designation brings development and marketing incentives, such as reduced fees, scientific advice and market exclusivity for 10 years upon regulatory approval
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- Ann: ATL1102 Orphan Drug Designation from EMA
Ann: ATL1102 Orphan Drug Designation from EMA, page-5
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