FM71 achieves all primary and secondary endpoints
Lighthouse | 31 August 2022
Trinity Delta view: The successful outcomes from the critical FM71 study pave the way for MED3000 to be submitted for FDA review, as a De Novo medical device, for the OTC treatment of erectile dysfunction. The dossier, including data from FM57, is expected to be submitted by end-September, with US marketing authorisation likely by end-Q123. The excellent safety and tolerability profile, coupled with the rapid onset of action and now demonstrated longer-term efficacy, means MED3000 is well positioned to become a clearly differentiated ED product. These clinical results now shift the focus from regulatory aspects to execution, much as the European CE Mark did in April 21. We expect discussions to address the commercially important US market will now begin in earnest. We currently value Futura Medical at £264m, equivalent to 92p per share but expect to review this as visibility on expected launch timings and likely commercial potential in the various markets increases.
31 August 2022
Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, a topically applied gel (MED3000), has been approved as an OTC product for ED (erectile dysfunction) in Europe, with final trials now complete in the US.
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