Trinity Delta view: The positive outcome of the critical US FM71 longer-term study for MED3000 removes clinical uncertainty, shifting the focus to regulatory and commercial execution. The MED3000 regulatory package for the OTC treatment of erectile dysfunction, including data from FM57, is expected to be submitted to the FDA by end-September and following five pre-submission meetings, a rapid review for a decision by end Q123 is hoped for. In parallel, the search for a US commercial partner has commenced, whilst in Europe a widespread deal with Cooper Consumer Healthcare is already in place. Our last published Futura Medical valuation was £264m, equivalent to 92p per share.
13 Sep 2022
Trinity Delta Lighthouse: Futura Medical
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Trinity Delta Lighthouse: Futura Medical
Futura Medical plc (FUM:LON) | 40.1 0.7 4.4% | Mkt Cap: 120.9m
- Published:
13 Sep 2022 -
Author:
Franc Gregori | Lala Gregorek | Philippa Gardner -
Pages:
2
Trinity Delta view: The positive outcome of the critical US FM71 longer-term study for MED3000 removes clinical uncertainty, shifting the focus to regulatory and commercial execution. The MED3000 regulatory package for the OTC treatment of erectile dysfunction, including data from FM57, is expected to be submitted to the FDA by end-September and following five pre-submission meetings, a rapid review for a decision by end Q123 is hoped for. In parallel, the search for a US commercial partner has commenced, whilst in Europe a widespread deal with Cooper Consumer Healthcare is already in place. Our last published Futura Medical valuation was £264m, equivalent to 92p per share.