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Thursday, August 18, 2016 12:19:30 PM
[img]Enamul Khan
Dear Sir/madam, I am writing to request for some more information regarding t...
11:32 AM (45 minutes ago)
Celia Economides <ceconomides@auriniapharma.com>
12:05 PM (13 minutes ago)
to me
Dear Enamul,
I’m the head of IR for Aurinia. Thank you for being a shareholder in the company and for your confidence in our results. We feel the same! I’ll point you to the press release that was issued on Monday: http://www.auriniapharma.com/dnn/LinkClick.aspx?fileticket=ifNeeSftXPk%3d&tabid=41&mid=570
It is clearly stated in the press release under safety: “There were 13 deaths across the trial: (2) in the high-dose voclosporin arm; (10) in the low-dose voclosporin arm (10); and (1) in the control arm, with the majority of overall deaths (11/13) occurring in Asia. All deaths were assessed by the Investigator as being unrelated to study treatment. No dose relationship was observed for the deaths.”
Furthermore, this was stated in our conference call prepared remarks: “Lastly, we know this is a serious and life-threatening disease, so deaths are largely expected across LN studies, which is an unfortunate part of treating this disease and somewhat unavoidable. Across the study, there were 13 deaths, with 11/13 occurring in Asia. The voclosporin high-dose arm has (2), the low-dose arm had (10) and the control arm had (1). ALL deaths were assessed by the Investigator as being UNRELATED to study treatment. There was no dose relationship observed for the deaths that occurred in the study.”
Lastly, as stated in our conference call, we will be updating the investment community with more data (once available) around the AURA study in the September/October time frame.
Thank you,
Celia[/img]
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