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Futura Medical PLC - Surrey-based pharmaceutical company - Says continues to progress along the regulatory timeline for MED3000, its topical gel formulation for treatment of erectile dysfunction.
Recently received pre-submission minutes of the US Food & Drug Administration meeting held in October.
"The minutes confirm the outline design of the requested supplemental clinical trial, known as "FM71" the parameters of which were broadly described in the update on 22 October 2020. Assuming it meets its primary endpoints, FM71 would provide the FDA with the necessary reassurance of MED3000's efficacy and safety for up to six months use by ED patients," says Futura.
Submits final detailed clinical study protocol to the FDA and a meeting has been scheduled for February 2021.
Adds that EU approval process continues to progress well, with the MED3000 technical file now actively under review by the regulator.
Current stock price: 14.50 pence
Year-to-date change: up 4.5%
By Lucy Heming;Â lucyheming@alliancenews.com
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