14th Jul 2020 21:51
Futura Medical PLC - the pharmaceutical company - Submits the product dossier for its treatment of erectile dysfunction known as MED3000 under the European Medical Device Regulation for marketing approval. The company has also now had a second pre-submission meeting with the US Food & Drug Administration, as a result of which it believes a pathway to a marketing approval for MED3000 in the US has been established, and importantly, without the need for a doctor's prescription. The US FDA have indicated a requirement for certain additional clinical efficacy data beyond Futura Medical's three months' home use study conducted in 2019 in 1,000 patients suffering from mild, moderate and severe erectile dysfunction. This additional data will require a further small clinical trial where patients with erectile dysfunction will receive MED3000 for a six month treatment period. Next steps will be to confirm design of the new clinical trial with US FDA to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the Over the Counter label and leaflet development.
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By Evelina Grecenko; [email protected]
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