Plethora Solutions Holdings Plc Share News (PLE)

Plethora Solutionas saw its value jump by around a third on Tuesday morning after it revealed a meeting with the US Food and Drug Administration (FDA) had resulted in a clear pathway to the successful submission of a new drug application. The application is for PSD 502, a drug used in the treatment of premature ejaculation, an area which the FDA confirmed was one of "high medical need", for which there is a requirement for effective therapy. "The company sees a significant potential market opportunity for PSD 502 both in the US and EU," it said. "Based on [its] internal modelling and pricing input from its US marketing consultant, the company forecasts in excess of $1bn per annum peak prescription sales."It also believes there is "significant value" in PSD 502 for shareholders, and as such, the group's management is looking to unlock that value "as quickly as possible" by bringing negotiations with potential marketing partners to close. It revealed it has received "several expressions of interest" for out-licensing PSD 502 in the US, EU and other territories. "Negotiations are at a more advanced stage with a number of potential marketing partners and the company is hopeful that an announcement will be made in this regard over the coming months," it said. However, it stressed it was not possible to accurately determine the timing of completion or terms of the agreements."The company is also making excellent progress with its preferred manufacturing partner and is hopeful that an announcement will be made within the next month," it added. Shares rose 35.53% to 12.20p by 10:42 Tuesday.NR