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Futura Medical files for pre-submission meeting with the FDA for MED3000

Futura has filed for a further pre-submission meeting with the FDA to follow up the initial presentation of existing clinical evidence from the FM57 study to the FDA in February

Futura Medical PLC -
MED3000 is a breakthrough treatment for erectile dysfunction

Futura Medical PLC (LON:FUM) said it has received the clinical study report (CSR) for its phase 3 study (FM57) into erectile dysfunction.

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.

READ Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results

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.

Quick facts: Futura Medical PLC

Price: 14.25 GBX

AIM:FUM
Market: AIM
Market Cap: £35 m
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Futura Medical kicks off work on Phase III trial for erectile dysfunction gel

James Barder, chief executive of Futura Medical PLC (LON:FUM), tells Proactive they've begun preparatory work on the first Phase III efficacy trial for MED2002 - their topical gel for erectile dysfunction (ED). The study will recruit approximately 1,000 patients with mild, moderate and...

on 27/4/18

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