RE: MED3000 Efficacy15 Mar 2021 13:11
Hi b3ar1sh, here's an extract from the rns dated 28 October:
The Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of this small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. The final study protocol can only be completed once the FDA minutes have been received. However, based on the pre-submission discussions FM71 is expected to be a comparative, randomised, open label, home use, parallel group study in approximately 100 patients with erectile dysfunction. Approximately 20 subjects will be located in the United States to provide reassurance that data generated outside the US is comparable to the US population. As an open-label design the study will be neither placebo controlled nor double-blinded, the study's primary endpoint will be to compare MED3000 against a pre-treatment baseline for efficacy for up to six months. The lowest "on demand" dose of tadalafil, 5mg (Cialis) will also be measured against pre-treatment baseline to enable the FDA to compare an overall risk/benefit analysis of the two treatments for the 6 month period of the study looking at efficacy, speed of onset and safety. 50 patients with ED will be included in each treatment arm of the study.