Well after all the earlier promises, now slightly overdue and the SMA chart starting to indicate a reversal of fortune I think you might be wise to buy some. Or if you hold some, top up as I've been doing lately.

For those not familiar with this stock check on previous news over the last year or so re 'promises'.

Closed up just under 26%

hope you are in dc - another fantastic day
atb

:-))

looking strong before eu approval rubber stamping rns now the merlin overhang cleared

Directors dealings - (Buys) -

Chairman J Mellon 20,000,000 £1.8 million 1Nov

ce and cfo R Openshaw 333,500 £30,015 1 Nov


Dr. GH Bailey 55,600 £5,004 1 Nov


Dr. MG Wyllie 333,500 £30,015 1 Nov



All Dealings at 9p

FULLY APPROVED RNS CONFIRMS - GOING TO BE A MAD RUSH THIS MORNING................. kerrrrrrrrrrrrrrrchinnnnnnnnnnngggggggggggggggggggggggg


RNS


RNS Number : 3479T

Plethora Solutions Holdings PLC

19 November 2013








19 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

European Commission Approval





Plethora Solutions Holdings plc (AIM: PLE) announces that the European Commission has granted marketing authorisation for the Company's treatment for primary premature ejaculation in adult men under the name 'Prilocaine Lidocaine Plethora'. This product is also referred to by the Company under its development code PSD502.



PSD502 was developed by the Company for the treatment of primary premature ejaculation and demonstrated a highly statistically and clinically significant improvement in the primary measures of intravaginal ejaculation latency time (IELT), control and satisfaction in two pivotal, double-blind, placebo controlled phase III studies. In these studies, the product was shown in over 23,000 exposures to be well accepted by patients.



Premature ejaculation is probably the most prevalent sexual dysfunction in men. The condition has been characterised by the International Society of Sexual Medicine (ISSM) as being "a male sexual dysfunction" characterised by: ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy.



The Company estimates that there are in excess of 150 million men aged between 20-69 years old in the European Union. With an estimated incidence of PE of 20-30% of men, this implies that the potential population of men in the EU with the disorder is approximately 30-45 million.



Jim Mellon Chairman of Plethora said:



"Plethora was founded in 2004 to develop PSD502; in 2011 the Company regained control of the European approval process and PSD502 has now been approved by the European Commission. In August this year Plethora regained global control of PSD502 and work is well underway to file with the FDA in early New Year. We are delighted by today's news that represents an important step in the successful commercialisation of the product. Premature ejaculation can cause serious distress for those men who suffer from the condition and we hope that PSD502 will help them and their partners"

UPDATE - Plethora Solutions granted EU marketing approval
By Jamie Nimmo November 19 2013, 12:40pm The company estimates 30-45mln men between 20 and 69 years old in the EU suffer from premature ejaculationThe company estimates 30-45mln men between 20 and 69 years old in the EU suffer from premature ejaculation

--ADDS SHARE PRICE, BROKER COMMENTS--

Plethora Solutions’ (LON:PLE) treatment for premature ejaculation has been granted marketing authorisation by the EU’s executive body, the European Commission (EC).

In September, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) advised the EC to approve PSD502, which will go under the name ‘Prilocaine Lidocaine Plethora’.

The company estimates 30-45mln men between 20 and 69 years old in the EU suffer from the sexual dysfunction.

Chairman Jim Mellon said: “Plethora was founded in 2004 to develop PSD502; in 2011 the company regained control of the European approval process and PSD502 has now been approved by the European Commission.

“In August this year Plethora regained global control of PSD502 and work is well underway to file with the FDA [US Food and Drug Administration] in early New Year.”

He continued: “We are delighted by today's news that represents an important step in the successful commercialisation of the product.

“Premature ejaculation can cause serious distress for those men who suffer from the condition and we hope that PSD502 will help them and their partners.”

Broker Daniel Stewart estimates that the group could receive approval to the US market in the second half of 2015.

It lifts its target price from 15.7p to 18.9p to reflect the lower risk associated with investing in the company now it has secured the EC approval.

“Finally, we reiterate our belief that PSD502 has the potential to go mass-market,” said the broker, which believes such an outcome would transform Plethora into a “large business”.

Plethora’s shares spiked in early deals but settled 3% higher at 17.1p. They have risen over 1,000% in the past six months.

good post dc - ple is looking a good buy in level right now - also tipped in the daily mail this morning

gl

Commercial Update

RNS


RNS Number : 6850T

Plethora Solutions Holdings PLC

22 November 2013










22 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")


Commercial Update





Plethora Solutions Holdings plc (AIM: PLE) provides a commercial update following the announcement on 19 November 2013 of the approval of PSD502, (under the name 'Prilocaine Lidocaine Plethora') by the European Commission.



As part of its disciplined approach to increasing shareholder value, it remains the Company's strategy that PSD502 will be brought to market via partners with the sales, marketing, and distribution infrastructure to maximise the commercial potential from the product.



During 2013, the Company expanded its business development activities by retaining external consultants with expertise in identifying and securing licensing partners and in negotiating these transactions. Since the appointment of these consultants, business development activity has increased significantly. The Company is engaged in dialogue with multiple parties, including major pharmaceutical companies, for a launch of the product, with the initial focus being on the markets within the European Union, the United States (subject to regulatory approval) and other selected territories.



Given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof. The Company is, however, confident that given the number of parties with which it is talking and the nature of those talks, one or more partners will be secured to lead to a successful commercialisation of PSD 502.



Concurrent with and based on feedback from the licensing activities, the Company is finalising its manufacturing strategy and has identified the lead manufacturer. Plethora will not manufacture the product directly but will either have the product manufactured by a subcontractor or license manufacturing to the marketing partners. In addition, the Company has used this opportunity, at the suggestion of several potential marketing partners, to initiate the development of a canister containing fewer doses. This has been undertaken to develop the marketed product on a cost basis that will maximise the commercial return. The timing of the availability of product will drive eventual launch dates ranging from mid to late 2014.





In addition to the European commercialisation, the Company has significantly advanced its preparation for the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA). The Company believes that the commercial potential in the US is at least as great as that in Europe. Over the coming months, the Company anticipates, as it did with the European filing, to announce progress along various steps with the US approval process.



The Company will provide further commercial updates as matters develop.



Jim Mellon Chairman of Plethora said:



"The European approval is terrific news for the Company and in it delivering shareholder value. The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the Company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales. The Company intends to see the launch of PSD502 at the earliest possible opportunity."





-Ends-

Plethora Solutions in talks with pharma majors over product launch
By Jamie Nimmo November 22 2013, 7:36am Plethora says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”Plethora says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”

Plethora Solutions (LON:PLE) has revealed it is in talks with a number of parties, including major drugmakers, over the launch of its treatment for premature ejaculation.

The AIM-listed company has just been given the go-ahead to launch the treatment across Europe and it says it is still planning to enlist the help of partners to bring PSD502, under the name ‘Prilocaine Lidocaine Plethora’, to market.

It says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”.

This year, it has recruited external consultants to negotiate such a deal, with the initial focus on the European and US markets.

Despite cautioning on the timing and details of a deal, the company said it is confident that “given the number of parties with which it is talking and the nature of those talks”, one or more partners will be secured.

Plethora added that it has identified a lead manufacturer of the product and has pencilled in a launch date ranging from mid-to-late 2014.

Chairman Jim Mellon said: “The European approval is terrific news for the company and in it delivering shareholder value.

“The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales.

“The company intends to see the launch of PSD502 at the earliest possible opportunity,” he added.

this has been three bagger for me so far...lots more to come! (imho)

Resignation of CEO

RNS


RNS Number : 1272U

Plethora Solutions Holdings PLC

28 November 2013








28 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Resignation of CEO





Plethora Solutions Holdings plc (AIM: PLE) announces that it has agreed with Ronald Openshaw that he will step down from the board and resign as Chief Executive Officer on 30 November 2013. Ronald has concluded that he wishes to devote his time to his consulting firm Lucia Capital LLP.



Ronald commenced his involvement with Plethora in early 2009 when he became interim CFO. In 2009 he led the Company's efforts to restructure its debt obligations which concluded with the Termination and Release Agreement with Paul Capital and the full repayment of the loans to ETV Capital.



At the beginning of 2011, Ronald was appointed the Company's CEO following the serious illness of the previous CEO.



In 2011, Ronald negotiated the first agreement to return economic and operational control in Europe and the Rest of the World (excluding certain territories) to PSD502, the Company's treatment for premature ejaculation, from Shionogi. Concurrent with that transaction a fundraising was completed which was corner-stoned by Jim Mellon, now the Company's Chairman. That agreement paved the way for the submission of the European dossier to the European Medicines Agency for the centralised approval of PSD502. On 19 November 2013, the Company announced that the European Commission had granted a marketing authorisation for PSD502 under the name 'Prilocaine Lidocaine Plethora'.



In August 2013, Ronald concluded the agreement with Shionogi for the return of the economic and operational control for the remaining rights to PSD502 in North America, South America, Japan, Korea, Taiwan and China. This will lead to the submission in 2014 of a New Drug Application to the US Food and Drug Administration. Following this and the CHMP opinion Ronald co-ordinated a financing to raise £4.4 million which was announced in October 2013.



Following Mr Openhaw's resignation, the board has asked Mike Collis to act as Chief Financial Officer on a part time basis with effect from 1 December 2013. Mr Collis was appointed to the board on 9 September 2013 as a non-executive director. In addition, Romero Tayong will be appointed as Company Secretary. Mr Tayong is the Company's Financial Controller and has worked with the Company since 2008. He is a Certified Accountant.



Jim Mellon, Chairman of Plethora said:



"The Company is indebted to Ronald who has led the financial restructuring of the business, the return of the global rights to PSD502 and the European approval of the product. Through his efforts, Plethora has been restructured and is now well financed to deliver upon its objectives of commercialising PSD502 on an international basis. We thank Ronald for his efforts and achievements and wish him well in his next ventures. In due course, the Company intends to further strengthen the management team and a further announcement will be made when appropriate."

Award of LTIPs & Issue of Ordinary Shares

RNS


RNS Number : 2242U

Plethora Solutions Holdings PLC

29 November 2013










29 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Award of LTIPs & Issue of Ordinary Shares





Plethora (AIM: PLE) announces it has awarded shares in relation to the Company's Long Term Incentive Plan ("LTIP") and has issued new ordinary shares in Plethora in relation to a number of agreements.



LTIP Award to Prof Wyllie



Plethora has today made an award of 16.5 million new ordinary shares to Prof Mike Wyllie, the Company's Chief Scientific Officer, under the Company's LTIP established in 2009. The award is subject to the achievement of certain performance conditions in relation to the regulatory approval process of PSD502 in the US, the signature of licensing transactions, and the establishment of new or the extension of further intellectual property over PSD502. In addition, the award is subject to the continued employment or directorship of Prof Wyllie for the next three years.





Issuance of shares



Plethora also announces that it has allotted 6,279,407 new ordinary shares of 1p each ("New Shares"), fully paid conditional only upon admission, to trading on AIM in relation to:



(i) the issuance of 1,355,975 New Shares in connection with awards made in 2010 which have now matured under the Company's LTIP;



(ii) the issuance of 923,432 New Shares in settlement of directors fees due in relation to Jim Mellon and Mike Collis; and



(iii) the issuance of 4,000,000 New Shares as an award to Ronald Openshaw that would otherwise have accrued under the company's LTIP.



Application will be made for the 6,279,407 New Shares to be admitted to trading on AIM ("Admission") and it is expected that Admission will take place on 4 December 2013.



Following Admission, the Company will have 415,274,582 ordinary shares in issue. The Company does not hold any ordinary shares in treasury. Therefore the total number of ordinary shares in the Company with voting rights is 415,274,582.



The above figure may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the Financial Conduct Authority's Disclosure and Transparency Rules.







-Ends-

Plethora Solutions welcomes Jamie Gibson as new CEO

By Giles Gwinnett

December 20 2013, 3:51pm
He has spent most of his professional career working with Plethora chairman Jim Mellon at Regent Pacific Group specialising in corporate finance and direct equity investments



Jamie Gibson has been appointed the new chief executive at Plethora Solutions (LON:PLE) starting January 1.

Gibson, 47, is tasked with driving the commercialisation of the firm's treatment for premature ejaculation PSD502 and leading initiatives on manufacturing strategy.

He has spent most of his professional career working with Plethora chairman Jim Mellon at Regent Pacific Group specialising in corporate finance and direct equity investments.

Mellon said: "We welcome Jamie whom I have worked with at Regent Pacific for over 17 years; we wish him every success in his new role.

"We are extremely pleased to have such an experienced team lead our business development activities, which is part of the company's disciplined approach to increasing shareholder value through the successful commercialisation of PSD502."

Reading Shares - For a company Plethora's size the potential of its product is a crucial factor for investors when deciding to back the stock. The company has an offering larger companies would pay to own in their search to replace lost income.

Company update

RNS


RNS Number : 9983B

Plethora Solutions Holdings PLC

11 March 2014










11 March 2014



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Company update



Plethora (AIM: PLE) is pleased to inform shareholders that our recent meeting during Q1 2014 with the United States Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application for PSD 502. Appropriate actions are well underway with the Company's various consultants. Importantly, the FDA has confirmed that premature ejaculation is an area of high medical need with a requirement for effective therapy and recognises the importance of the initiatives that Plethora has made towards this goal.

The Company sees a significant potential market opportunity for PSD 502 both in the United States and EU. Based on the Company's internal modeling and pricing input from its US marketing consultant, the Company forecasts in excess of US$1 billion per annum peak prescription sales. It therefore sees significant value in PSD 502 for the Company's shareholders and correspondingly, management is to looking to unlock that value as quickly as possible through bringing to closure negotiations with potential marketing partners. In this respect, the Company 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. However, shareholders should please note that given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof.

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.

Plethora Solutions eyeing US$1bn a year in sales

By Giles Gwinnett

March 11 2014, 8:46am
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales


Plethora Solutions (LON:PLE) shares raced up Tuesday as it reported positive progress in the USA for its lead product, PSD 502 for premature ejaculation.

The firm's recent meeting with the United States Food and Drug Administration (FDA) has now "unambiguously defined the path" to a successful submission for making a drug application for 502, said the company, which now forecasts more than US$1 billion per annum peak prescription sales.

Investors hailed the brief statement, sending shares up over 22% to 11 pence each.

The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant means it now forecasts more than US$1 billion per annum peak prescription sales.

The firm said it's looking to unlock value as quickly as possible through bringing to closure negotiations with potential marketing partners for PSD 502.

"In this respect, the company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories," it said.

Negotiations are at a more advanced stage with a number of potential marketing partners and Plethora said it was hopeful that an announcement will be made over the coming months.

"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."
--------------------------------------------------------------------------------------------

UPDATE - Plethora Solutions eyeing US$1bn a year in sales

By Giles Gwinnett

March 11 2014, 5:46pm
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales


--ADDS BROKER COMMENT--

Plethora Solutions (LON:PLE) shares soared on Tuesday as it reported positive progress in the USA for its lead product for premature ejaculation.

The firm's recent meeting with the United States Food and Drug Administration (FDA) has now "unambiguously defined the path" to a successful submission for making a drug application for PSD 502.

The AIM-listed company saw its shares jump 24% to 11.1p on the news.

The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant means it now forecasts more than US$1 billion a year in peak prescription sales.

The firm said it is looking to unlock value as quickly as possible by bringing to a close negotiations with potential marketing partners for PSD 502.

“In this respect, the company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories,” it said.

Negotiations are at a more advanced stage with a number of potential marketing partners.

“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.

The shares have put on 550% since trading at just 2p a year ago amid funding issues.

Daniel Stewart lifted its target price on the stock from 18.9p to 25.6p on Tuesday, reducing its discount rate from 19% to 15% in its DCF (discounted cash flow) model now that the treatment is closer to being awarded US approval.

“We continue to see significant scope for reducing our conservative discount rate, and hence increasing our target price, as PSD502 further progresses through to US approval and commercial launch,” analyst Vadim Alexandre said.

Plethora Solutions: Daniel Stewart moves shifts target price from 18.9p to 25.6p and keeps a buy recommendation.

Another 10% today