Futura Medical PLC - pharmaceutical company headquartered in Guildford - Gets positive quality management systems audit opinion on topical gel formulation treatment for erectile dysfunction product MED3000. This is part of Futura's formal proceedings to obtain approval for MED3000 as a medical device and clinical proven ED treatment in Europe by a EU notified body. Pre-marketing clearance requires submission of technical documentation including safety data as well as proof the company can operate to a high standard of quality through a QMS. This positive audit opinion means that Futura's QMS meets the standard needed for new medical device regulations. Futura seeks to have MED3000 approved as an over-the-counter treatment as well as on prescription. Successful approval would mean the product could be marketed in the EU and UK without the need for a prescription, subject to national restrictions.
Chief Executive James Barder said: "We are pleased to have fulfilled the key filing requirements for MED3000 for European approval as a clinically proven treatment for ED. In parallel with the regulatory processes and executing upon our strategic plans, Futura has now appointed specialised corporate advisers with international experience to facilitate commercial discussions with potential licensing and marketing partners."
Current stock price: 18.10 pence
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By Anna Farley; annafarley@alliancenews.com
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Futura Medical (FUM)