Plethora Solutions (LON:PLE) shares tanked as it reported widening losses last year and it continues to seek FDA approval for its premature ejaculation treatment, FORTACIN, in the US.
A pathway to US approval for FORTACIN necessitates further clinical trials to be carried out, which Plethora will start later this year.
These will take around five months to complete at cost of around US$5 million, the firm told investors.
A new dossier for FDA application is expected to be put in during Q1 2016 and a target launch of PSD502 in the USA is anticipated to take place during the first part of 2017.
The firm also said it was preparing for an initial commercial launch of the product in the EU and other territories.
The loss for continuing operations for the year to December 31 was £15.7mln compared to a loss of £8.8mln in 2013, while the loss per share went to 3.2p (2013: loss of 2.6p).
Among other developments in 2014 was that a decision was made to explore the re-design of the existing approved 20 dose canister to a smaller six dose container to reduce the unit cost of each.
However, this would change the existing EMA approval necessitating a new application to the regulator, the firm said.
Shares sank over 34% to 3.875p.