FUTURA MEDICAL WKN: 911670 ISIN: GB0033278473 Forum: Aktien Thema: Hauptdiskussion

Die Anteile an   Futura Medical (FUM  ) stiegen heute um über 100%, nachdem sie den Anlegern mitgeteilt hatten, dass die EU-benannte Stelle das MED3000-Gel der Gruppe als zugelassenes Medizinprodukt der Klasse 2B zertifizieren soll.  Folgen Nach Erhalt dieses Zertifikats wird Futuras topische Gelformulierung MED3000, die als "Durchbruch" bezeichnet wird, die erste europaweite topische Behandlung für erektile Dysfunktion ("ED") sein, die ohne ärztliche Verschreibung erhältlich ist.  Futura reichte Mitte Juli 2020 das Technische Dossier für MED3000 zur Behandlung von ED gemäß der Europäischen Medizinprodukteverordnung zur Marktzulassung in Europa durch eine EU-benannte Stelle ein, um die europäische Zulassung im Jahr 2021 zu erreichen.  Heute heißt es, dass die europäische Zulassung für MED3000 mit der Ausstellung eines Zertifikats zur Verordnung über Medizinprodukte durch das Gremium, das vor Ende Mai 2021 erwartet wird, endgültig sein wird.  Sobald die EU-Zertifizierung und das daraus resultierende CE-Zeichen erteilt wurden, ebnet dies den Weg für eine rasche weltweite Zulassung, insbesondere in Regionen wie dem Nahen Osten, Afrika, Fernost und Lateinamerika, die aufgrund ihrer Anerkennung eine "schnelle" Überprüfung ermöglichen das EU-CE-Zeichen.  Die CE-Kennzeichnung wird auch in Großbritannien bis zum 30. Juni 2023 anerkannt und wird im Zeitraum vor dieser Futura die neue UKCA-Kennzeichnung nach dem Brexit erhalten. Es heißt, dies werde ein rationalisierter Prozess sein, da davon ausgegangen wird, dass der britische Antrag eine Brücke zur EU-Zulassung schlagen kann.  In der Zwischenzeit teilte Futura den Investoren mit, dass die Marktzulassung für MED3000 in den USA zur Verwendung als nicht verschreibungspflichtige, klinisch erprobte Behandlung von ED weiter vorangetrieben wird.    Futura sagte, es habe "ein konstruktives 4. Treffen" mit der FDA gehabt, um das Protokoll der klinischen Studie für die erforderliche kleine Zusatzstudie abzuschließen, und warte auf das Protokoll des letzten Treffens.  Die Aktien von Futura Medical haben seit Jahresbeginn um fast 80% an Wert gewonnen, während die Aktie heute Morgen nach der Ankündigung um 127,78% auf 41 Pence gestiegen ist.  Futura said MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs across all patient severities in the $5.6bn global ED market, as well as to become the first globally available, clinically proven, over the counter ED treatments.  Futura noted that the prevalence of ED disrupts the lives of at least 1 in 5 men globally, with around 23 million men in the US and 20 million men in the UK, France, Italy and Germany. To date, the space has seen little to no innovation in ED treatments in over ten years with many patients continuing to suffer dissatisfaction with existing treatments on offer, it said.  On the commercial side, Futura said it has been working with retained specialised corporate advisers on active commercial discussions with potential licensing and marketing partners.  Following the Company's recent announcement of a Joint Collaboration agreement for the China and the South East Asia region, the group said partnering discussions for other countries continue in line with the agreed process being managed by its corporate advisers.  The Company said it has now received initial offers from a number of parties. In addition, the group said it believes that the EU approval of MED3000 will assist the Company in its objective of delivering long-term, sustainable value through the licensing of MED3000.  "The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000. We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset,” said James Barder, CEO of Futura.  He added, “Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions. This will represent a significant commercial opportunity."  Follow News & Updates from  Futura Medical  here:  Folgen   Disclaimer & Declaration of Interest The information, investment views and recommendations in this article are provided for general information purposes only. 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