https://seekingalpha.com/article/440389 ... transcript
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The application comes after the drug showed statistically significant and clinically meaningful improvements in sleep duration and patient-perceived sleep quantity and quality in the phase 3 registration program.
Subject to the US Food and Drug Administration's approval, the biotech company expects to launch the drug in the US in the first half of 2022.
The company's shares rose about 1% at the end of trading on Tuesday.
They did it!!!! Ponvory goedgekeurd door FDA!!! 8% royalties!!!!