Question · Q4 2025
Salvatore Caruso inquired about the status of the MAA review in Europe, specifically if the market would be served by the Catalent Indiana facility and if the EMA has responded to FDA inspection findings.
Answer
David Hallal, Chairman and Chief Executive Officer, explained that mutual recognition between FDA and EMA means FDA's progress supports the EMA review. Akshay Vaishnaw, President of R&D, added that the EMA is aware and supportive, awaiting resolution of the Catalent issues.
Ask follow-up questions
Fintool can predict
SRRK's earnings beat/miss a week before the call