- (PLX AI) - Calliditas Updated regulatory timeline for review of MAA in Europe.
- • European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines, insted of accelerated assessment
- • Calliditas estimates a potential impact of 3 months on the previously communicated timelines
- • Calliditas estimates expected decision by EMA in the first quarter, 2022
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