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Futura Medical says regulatory submissions are on track

The update was provided in a statement accompanying the firm's annual meeting

Futura Medical PLC -

Futura Medical PLC (LON:FUM) said it is seeing limited impact from the coronavirus lockdown and that regulatory submissions for its erectile dysfunction treatment remain on track.

The company has developed MED3000, a fast-acting gel that will be targeted at men for whom the current treatments don’t work.

WATCH: Futura Medical's James Barder says regulatory submissions for MED3000 remain on track

It is making a De Novo medical device application in the States for its breakthrough after a successful phase III clinical trial and is seeking sign-off in Europe too.

In an update contained in Futura’s AGM statement, investors were told that a second pre-submission meeting with the US Food & Drug Administration has been now set.

This could allow Futura to file for pre-marketing clearance by the end of the third quarter, it added.

In Europe, Futura said it had experienced no delays with its EU notified body as a result of the new medical device regulations or Covid with its technical dossier “nearing completion”.

Chairman John Clarke said: “As a breakthrough treatment for erectile dysfunction, we remain confident that we will receive MED3000 approval as a medical device and look forward to updating the market on Futura's developments during the remainder of 2020.”

In the same announcement, the research firm said it received a £2.2mln research and development tax credit from the UK tax authorities as it reiterated previous guidance that it has funds sufficient to see through to the second quarter of 2022.

Analysts at broker Liberum reiterated their 'buy' recommendation, saying: “Despite a strong recent performance there is still significant upside at Futura in our view given the string of upcoming catalysts and valuation with a market cap of just £44m versus a potential peak sales of >£300m.”

   --Adds broker comment--

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

2 min read