Jul 17, 2024 / 12:00PM GMT
Nikolaj Sorensen - Orexo AB - President, Chief Executive Officer
Welcome to this half-year interim report for Orexo, a quarter and half year which has been a little of a mixed back with some good progress, but also some areas where we have been surprised by a negative -- recent negative development. So I think the headline of today is probably the complete response letter we received on OX124 on -- very late on Tuesday evening and also the press release we had yesterday.
I would just start to say that for Orexo that we would receive a complete response letter was not a surprise. We had expected that. We did talk about that in our last-quarter report that we would be delayed, and that was due to the human factor study and the instructions for use that needed to be updated.
However, there were some requests for technical data that came as a surprise, and that requires a little more work from our side. But I will come back to that.
But I think the really positive thing is that there's only one problem in the complete response letter with the product, and that was related to the
Q2 2024 Orexo AB Earnings Call Transcript
Jul 17, 2024
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