Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript
Excellent. Listen, guys, thank you all for joining us. Greg, pleasure to have you here.
Questions & Answers
My first question to you: do you have a PDUFA date?
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
| Access to All Earning Calls and Stock Analysis | |
| 30-Year Financial on one screen | |
| All-in-one Stock Screener with unlimited filters | |
| Customizable Stock Dashboard | |
| Real Time Insider Trading Transactions | |
| 8,000+ Institutional investors’ 13F holdings | |
| Powerful Excel Add-in and Google sheets Add-on | |
| All data downloadable | |
| Quick customer support | |
| And much more... |
Trustpilot
We'd love to learn more about your experiences on GuruFocus.com and how we can improve!
Take Survey
