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Isofol Medical’s Q4 report was overall in line with our expectations. The phase III trial in mCRC is at a fork in the road, awaiting the DSMB’s recommendation on which path to take. While we expect an expansion by 220 to 660 patients (to demonstrate statistical significance on PFS), a decision to stop at 440 would not diminish the chances of regulatory approval, but signal somewhat higher commercial risk, in our view. However, not expanding the study would mean arfolitixorin reaching the market more rapidly. We have raised our fair value to SEK21–37 (14–28) on the back of estimate changes.
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