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Of course, most of the focus is on the extended FDA process for Nefecon and the likely clarification from the agency until the 15th of December. The FDA feedback will be followed by EMA feedback for Europe during Q1 2022. Naturally, the Q3 report does not reveal new details regarding these key near term value drivers. Calliditas continues to prepare for a favourable scenario and an early launch. The company s also ready to collaborate closely with the agency if the procedure continues to be delayed.
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