By Kyle Morris

Shares in Futura Medical PLC traded down 11% on Tuesday after the company said that the U.S. Food and Drug Administration has asked additional questions and requested some nonclinical confirmatory data related to its application for marketing authorization for MED3000.

The company expects said it will provide a response and the data no later than the end of March 2023. Based on FDA guidelines, the grant of the request is now expected in the second quarter, it said.

MED3000 is the company's gel formulation for treatment of erectile dysfunction.

"We are in constructive active dialogue with the FDA and believe we are making solid progress in our efforts to be granted [over-the-counter] marketing authorization for MED3000 by the FDA which is now anticipated in Q2 2023," Chief Executive James Barder said.

Shares at 0844 GMT were down 5.60 pence at 44.50 pence.

Write to Kyle Morris at kyle.morris@dowjones.com

(END) Dow Jones Newswires

March 14, 2023 05:11 ET (09:11 GMT)

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