FDA agrees with Avadel's (AVDL) proposed amendments to the statistical analysis plan for the REST-ON Phase 3 study for once-nightly sodium oxybate, FT218

Source Link:

https://www.globenewswire.com/news-release/2019/09/23/1919054/0/en/Avadel-Pharmaceuticals-Announces-FDA-Agreement-to-Reduce-the-Sample-Size-for-the-Ongoing-Pivotal-Phase-3-Study-for-Once-Nightly-FT218-Full-Enrollment-Now-Expected-by-End-of-2019.html