15th Sep 2021 20:23
Futura Medical PLC - Surrey-based pharmaceutical company - Says the first patient visit has occurred in the confirmatory clinical study, FM71, for MED3000 that will be supporting the US regulatory submission for the product. MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of erectile dysfunction.
Says start of FM71 is in line with planning and both the FM71 and non-clinical human factors studies are now progressing in parallel targeting patient completion by the end of the second quarter of 2022 in order for submission of MED3000 for US regulatory approval as a DeNovo medical device for ED treatment, with over-the-counter classification by end the third quarter 2022. US marketing authorisation therefore remains on track for approval of MED3000 in first quarter of 2023.
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By Arvind Bhunjun; [email protected]
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