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Isofol Medical: DSMB recommends 440 patients - DNB

Late on Friday, the DSMB gave its much-anticipated recommendation based on the interim analysis. Its recommendation to complete the ongoing phase III study with the 440 recruited patients surprised us, as we expected it to recommend expanding the study. In our view, this news does not diminish the chance of regulatory approval but does signal a somewhat higher commercial risk. Also, visibility on timelines is now clearer, with the results of the study expected in H1 2022 and sales in 2023. We reiterate our SEK21–37 fair value.l

Late on Friday, the DSMB gave its much-anticipated recommendation based on the interim analysis. Its recommendation to complete the ongoing phase III study with the 440 recruited patients surprised us, as we expected it to recommend expanding the study. In our view, this news does not diminish the chance of regulatory approval but does signal a somewhat higher commercial risk. Also, visibility on timelines is now clearer, with the results of the study expected in H1 2022 and sales in 2023. We reiterate our SEK21–37 fair value.l
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