Futura Medical’s update on MED3000, its novel treatment for erectile dysfunction (ED), confirms progress is in line with our expectations. The regulatory filings with both the US FDA and European Notified Body are progressing well. Importantly, the FDA has indicated there is a pathway for MED3000 to be launched as an OTC product in the US. This will require an additional, albeit modest, supplementary clinical trial to demonstrate longer term efficacy. More details should be known by the time of H120 results, likely in early-September. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.
11 Aug 2020
FDA green lights MED3000 for OTC approval
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FDA green lights MED3000 for OTC approval
Futura Medical plc (FUM:LON) | 36.0 0.2 1.5% | Mkt Cap: 108.4m
- Published:
11 Aug 2020 -
Author:
Lala Gregorek -
Pages:
3
Futura Medical’s update on MED3000, its novel treatment for erectile dysfunction (ED), confirms progress is in line with our expectations. The regulatory filings with both the US FDA and European Notified Body are progressing well. Importantly, the FDA has indicated there is a pathway for MED3000 to be launched as an OTC product in the US. This will require an additional, albeit modest, supplementary clinical trial to demonstrate longer term efficacy. More details should be known by the time of H120 results, likely in early-September. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.