As a result, the company added, it has now filed for a further pre-submission meeting with the US Food and Drug Administration (FDA) to follow up the initial presentation of existing clinical evidence from the FM57 study at an FDA pre-submission meeting on February 24, 2020.
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In a statement, Futura said it expects the further meeting with the FDA to take place in the next few months. If the outcome of the meeting is positive, this could lead to a US submission filing in the third quarter of this year for FDA review for pre-marketing clearance for its lead product, MED3000, a topical [applied to the skin] treatment for erectile dysfunction.
"Following extensive review of the clinical data, we are pleased to have received the completed and signed CSR for FM57, and have filed the necessary data in order for the company to have the next pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements for MED3000.
"As a breakthrough treatment for erectile dysfunction (ED), we are confident that we will receive MED3000 approval as a medical device, and we continue to target the next six months for regulatory submissions in both Europe and USA," said James Barder, the chief executive officer of Futura Medical.
Shares in Futura were up 3.9% at 10.65p in early trading.