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SENASTE
FDA regards Calliditas amended application as a major amendment very late in the approval process and extends the PDUFA (decision deadline) by 3 months from 15th September. Normally this is unusual, but FDA is not yet operating in line with Business as usual, and the number of extended PDUFA dates is high. Do we need to worry? Probably not, and the most likely scenario is a slight delay and a slight impact on cost and possibly Calliditas first-mover advantage. Our value proposition remains a base case of SEK 280 (Bull 450, Bear 125).
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