AVDL now up 84% and climbing at $1.97 with more than 79,000 trades and 46 million plus shares traded

On May 24, 2022, Avadel Pharmaceuticals plc (the “Company”) received a proposed, final label and medication guide for FT218 from the U.S. Food & Drug Administration (“FDA”). In addition, the Company was notified by FDA that the FT218 New Drug Application (“NDA”) patent statement pertaining to US Patent No. 8,731,963 (the “REMS patent”) was deemed inappropriate by FDA. As such, FDA has requested the Company add a certification to the REMS patent to its NDA. FDA further confirmed, based on the final proposed label, that no additional patent certifications will be required.

https://seekingalpha.com/news/3843054-avadel-stock-falls-25-as-fda-cites-patent-issue-in-sleep-disorder-drug-ft218-filing-expects-tentative-approval-in-2023

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