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
Avadel Pharmaceuticals plc - Ordinary Share (AVDL)
Last avadel pharmaceuticals plc - ordinary share earnings: 3/12 07:00 am
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Source: GlobeNewswire
FDA agrees with Company’s proposed changes to the statistical analysis plan for the REST-ON Phase 3 study for once-nightly sodium oxybate, FT218Reduces estimated time to completion by up to 12 months; now expected to complete patient enrollment by end of 2019, with pivotal data readout now expected in 2Q 2020 Enrollment currently at 193 patients for the REST-ON Phase 3 study (94% complete) Management to hold conference call today at 9:00 a.m. ET DUBLIN, Ireland, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, today announced that the U.S. Food and Drug Administration (FDA) has agreed to the Company’s proposed amendments to the statistical analysis plan and protocol under its special protocol assessment agreement (SPA), resulting in a lower sample size needed to demonstrate significance for both excessive daytime sleepiness and cataplexy in narcolepsy patients. No modif
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- Avadel Pharmaceuticals to Present at the 23rd Annual Needham Healthcare ConferenceGlobeNewswire
AVDL
Earnings
- 11/8/23 - Miss
AVDL
Sec Filings
- 4/15/24 - Form 8-A12B
- 4/15/24 - Form 8-K
- 3/4/24 - Form 8-K
- AVDL's page on the SEC website