Business
Update on MED3000 regulatory approval in the US
Update on MED3000 regulatory approval in the US.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n \n \n \n \n \n \n 29 March 2023\n \n \n \n \n \n \n \n \n \n Futura Medical plc\n \n \n (\"Futura\" or the \"Company\")\n \n \n \n Update on progress towards regulatory approval in the US\n \n \n \n \n \n \n \n \n Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today provides an update on US regulatory activities for MED3000,\n Futura's\n novel, topical gel formulation for the treatment of erectile dysfunction (\"ED\")\n .\n \n \n \n \n \n Following the FDA update provided by the Company on 14 March 2023, Futura can confirm\n that a full response to the FDA's questions, as well as the requested confirmatory data, has been resubmitted to enable the FDA to continue its review.\n \n \n \n \n \n Based on the FDA's published target review period guidelines which includes time to review the newly provided information, the Board continue to anticipate grant of the De Novo request in Q2 2023.\n \n \n \n \n \n \n \n \n \n -ENDS-\n \n \n \n \n \n \n For further information, please contact:\n \n \n \n \n \n \n \n \n Futura Medical plc\n \n \n \n James Barder, Chief Executive Officer\n \n \n Angela Hildreth, Finance Director and COO\n \n \n Email:\n \n \n [email protected]\n \n \n \n \n Tel: +44 (0) 1483 685 670\n \n \n \n \n www.futuramedical.com\n \n \n \n \n Nominated Adviser and Sole Broker:\n \n \n \n \n \n \n \n \n Liberum\n \n \n \n Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings\n \n \n Tel: +44 (0) 20 3100 2000\n \n \n \n \n \n For media enquiries please contact:\n \n \n \n \n \n \n \n \n Optimum Strategic Communications\n \n \n \n Mary Clark/ Hollie Vile/ Jonathan Edwards/ Zoe Bolt\n \n \n Email:\n [email protected]\n \n \n Tel: +44 (0) 203 882 9621\n \n \n \n \n \n \n About Futura Medical plc\n \n \n \n Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys®technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised f...