Ken James, the head of R&D at Futura Medical PLC (AIM:FUM, OTC:FAMDF), described as a "big deal" the approval by the US Food and Drug Administration (FDA) of the firm's MED3000 erectile dysfunction (ED) treatment.
In an interview with Proactive's Thomas Warner, James emphasised the significance of introducing the first over-the-counter (OTC) ED treatment in the US, the world's largest drug market.
The market appeared to share the Futura director's excitement as the shares jumped 16% to 49.9p. Broker Liberum reckons the stock is worth 141p.
In the interview, James also highlighted MED3000's unique feature, a faster onset time of 10 minutes compared to the 30 minutes of competing products. This characteristic, he believes, would make the treatment a standout in the market.
Reflecting on the rigorous FDA process, James lauded the regulator's supportive role while noting the high standards they set during the review.
The drugs watchdog required a comprehensive submission that included 22 separate reports, from clinical studies to safety assessments.
He described overcoming the FDA's high bar as a challenging journey that was nonetheless rewarding with the approval announced recently.
In terms of future plans, James hinted at ongoing discussions about partnering, expecting positive outcomes now that the FDA approval is secured. He was, however, unable to divulge further details.
The interview also touched on the exercise of some warrants by one of Futura's long-term investors, Lombard.
Expressing gratitude for Lombard's support, James confirmed the move would provide additional cash of about £4mln.