Dec 01, 2021 / 02:15PM GMT
Umer Raffat - Evercore Inc. - Analyst
Excellent. Listen, guys, thank you all for joining us. Greg, pleasure to have you here.
Questions and Answers:
Umer Raffat - Evercore Inc. - AnalystMy first question to you: do you have a PDUFA date?
Greg Divis - Avadel Pharmaceuticals plc - CEO
Yes. Umer, first, thanks for the opportunity to be a part of the conference. We appreciate the chance to participate. What we've communicated to date is that the FDA informed us back in mid-October that they weren't going to be able to meet the action date of October 15th. And they, quite frankly, needed more time to complete their review and that they wouldn't finish their review in October.
So since then, we've not been provided a new action date specifically, just to answer your question directly. At this point in time, based on what we know today and the interactions we've had to date and where the review stands, we don't expect a formal action to occur that would actually result in a new PDUFA date, whether that's a
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