Q4 2023 Calliditas Therapeutics AB Earnings Call Transcript
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Thank you very much, and welcome to the Q4 2023 presentation. I'd like to draw your attention, first of all, to the disclaimer notice as usual, which covers forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. And I refer you to public filings, including those containing risk factors.
Next page, please. So with regards to Q4, and to start just with some highlights, so obviously the key event for this quarter was December 20, the FDA granted us full approval of TARPEYO based on the submission of the full Phase 3 data set, which we filed in June 2023.
The Phase 3 trial showed a highly statistically significant outcome on the primary endpoint of eGFR with a p-value of less than 0.0001. Additional supportive data obviously is being presented on conferences and in other place in terms of slope analysis, three mils per minute per year in favor of TARPEYO versus placebo, a statistically significant impact on microhematuria and biomarkers such
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