EU Notified Body recommends MED3000 approval
Lighthouse | 19 March 2021
Trinity Delta view: MED3000’s regulatory approval in Europe de-risks the Futura Medical investment case, removing a major uncertainty and paving the way for commercialisation discussions for a number of geographies to proceed at pace. The major sensitivities in these markets now shift from regulatory risk to execution risk. In the US, the outcome of the fourth meeting with the FDA is awaited, but it is unlikely any major unknowns will be revealed. We are maintaining our Futura Medical valuation, based on conservative assumptions, at £181.5m or 73.1p per share (71.3p fully diluted) until we have further clarity on the likely structure and economics of commercialisation deals across EU (and other) markets.
19 March 2021
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 in Europe as a medical device for ED (erectile dysfunction), with the US awaiting a final confirmatory study.
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