Futura Medical PLC - Surrey, England-based sexual health-focused pharmaceutical company - Says it has submitted a full response to questions from the US Food & Drug Administration and confirmatory data regarding its MED3000 erectile dysfunction treatment. This is for the FDA to continue its review of the product. Notes that it expects the grant of the De Novo request in the second quarter of 2023. A De Novo classification by the FDA provides an alternate pathway to marketing approval for novel medical devices.
Current stock price: 45.24 pence, up 6.5% on Wednesday
12-month change: up 83%
By Harvey Dorset, Alliance News reporter
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Futura Medical (FUM)