MED3000 European regulatory pathway is clearer
Lighthouse | 17 February 2020
Trinity Delta view: The remarkable FM57 pivotal study results have created understandable uncertainty. However, there are material commercial opportunities for MED3000 to be approved as a treatment for ED, including the extended patent life and wider market opportunities, eg use with existing ED medications such as PDE5 inhibitors. Clearly there are significant potential unknowns that remain. The positive interactions with the European regulators bring a welcome improved clarity to the likely approval pathway. The planned meeting with the FDA this quarter will shed further light on the next steps for the important US market. We suspended our forecasts and valuation at the time of the FM57 results and intend to reinstate them as soon as practicable.
17 February 2020
Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, MED3000, a topically applied gel, is being developed for erectile dysfunction (ED). A pain relief gel, TPR100, is awaiting UK approval.
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