Our strategy is to develop our portfolio of innovative products for two large market categories, sexual health and pain to late stage, and then partner with major partners at the optimum time to generate most value.
The objective is to develop products such that each on its own has the potential to generate significant annual revenues.
We are investing in our lead product MED3000 to generate most value for shareholders.
The regulatory dossier for MED3000 was submitted in the EU and three pre-submission meetings took place with the FDA in 2020 with a further meeting in February 2021.
US: Commencement of Phase 3 small supplementary study FM71 required for the US submission.
EU and UK: Following EU approval of MED3000 as a medical device, we are now focused on manufacturing scale-up and completion of licensing agreements in preparation for the initial launches of MED3000.
We are focused on innovative products that are highly differentiated in their markets.
The regulatory strategy and requirements for MED3000 as a medical device to be available without the need for a doctor’s prescription was defined and accepted by both the EU and US regulatory authorities, with MED3000 having the potential to be the first OTC treatment for ED in the US and most countries around the world.
Resources are focused on the commencement of FM71 and the licensing of MED3000.
We aim to improve treatments to give more choice to patients and doctors and improve the quality of life of those suffering from ED and local pain.
We raised awareness of the mode of action of MED3000 and the unique benefits of MED3000 for ED sufferers.
Ensure men with erectile dysfunction can have access to MED3000 as quickly as possible and continue to develop CBD100 with our partner CBDerma Technology.
We are focused on increasing value for shareholders and the quality of life for patients.
We raised the profile of MED3000 as a commercial asset and are in active discussions with potential partner(s) for the licensing rights having announced a joint collaboration with Co-High for China and South East Asia in March 2021.
Out-license the rights to MED3000 to build sustainable long-term value for shareholders.