Q3 2023 Calliditas Therapeutics AB Earnings Call Transcript
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Thank you and welcome to this Q3 report. I am joined here today by Richard Philipson, our Chief Medical Officer; Fredrik Johansson, our Chief Financial Officer; and Andrew Udell, President of North America.
I would like to draw your attention to the disclaimer page 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.
So looking a little bit at the Q3 highlights. So during the quarter, we filed for full approval of TARPEYO with the FDA based on our full Phase-3 data, and also support our partner STADA in filing for standard marketing authorization with EMA.
The FDA granted us priority review in August, and our target PDUFA date is December 20. We also saw the publication in The Lancet of our successful Phase-3 results, which was very well received by the nephrology community. And as we subsequently attended the IIgANN conference in late
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