Aug 13, 2021 / 08:00AM GMT
Martin Amark - Xbrane Biopharma AB(publ)-CEO
Thank you very much, and hello, everybody. Thanks for calling in. We are here to present the Q2 report of Xbrane Biopharma, and we go to page 3. So just going through some of the highlights of the second quarter of 2021, we can start with our Xlucane program, our biosimilar candidate to Lucentis. We were pleased to receive a positive topline data from the interim readout which we did in the ongoing pivotal Phase 3 trial. And that then triggered a confirmation of our plan to submit the marketing authorization application to EMA, the European regulatory authority, and that will be done next month. It's practically finalized. We worked a lot with that document throughout the year but intensively during the summer, and it will be submitted during the course of September.
When it comes to the Biologics License Application to FDA in the US, it's now planned for the fourth quarter of this year, but we are going to have a meeting with the FDA in August where that exact plan and the final date will be confirmed, a final date
Q2 2021 Xbrane Biopharma AB Earnings Call Transcript
Aug 13, 2021
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