Avadel Pharmaceuticals PLC Announces FDA Agreement to Reduce the Sample Size for the Ongoing Pivotal Phase 3 Study Transcript
Greetings. Welcome to the Avadel Update Call.
(Operator Instructions) I'll now turn the conference over to Mike Kanan. Mike, you may now begin.
Thank you, and good morning, and thank you for joining us on our conference call.
This morning, we issued our press release announcing an agreement with the FDA to amend our FT218 Phase III REST-ON pivotal study that is under a special protocol assessment agreement with the FDA. The release can be accessed on our website at www.avadel.com.
As a reminder before we begin, the following presentation includes a number of matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the
| 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
