24th Jun 2020 11:45
(Alliance News) - Futura Medical PLC on Wednesday said its drug development and commercialisation operations continue despite coronavirus.
Ahead of its annual general meeting, the AIM-listed pharmaceutical company reported that the impact of Covid-19 on the company has been limited to date.
Futura said it continues to target submission of the regulatory dossier for MED3000 to the US Food & Drug Administration by the end of the third quarter of 2020 after a new patent application was filed in December 2019.
Back then, headline data from the FM57 clinical study demonstrated that MED3000 has the potential to be a treatment for erectile dysfunction with a rapid onset of action and excellent safety profile, Futura Medical said.
At the end of February, the US FDA agreed to a De Novo medical device application for MED3000 and invited Futura to pursue another pre-submission meeting.
At the end of April, the company said it had filed for a further pre-submission meeting with the US FDA in the coming months. This meeting date has now been set, Futura said, and will be used to further discuss clinical sufficiency following completion of FM57's clinical study report.
Simultaneously, Futura commenced formal proceedings for MED3000 to be approved as a medical device and clinically proven treatment for erectile dysfunction in Europe.
Futura shares were trading 0.3% higher in London on Wednesday at 18.30 pence each.
By Evelina Grecenko; [email protected]
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