Less Ads, More Data, More Tools Register for FREE

Pin to quick picksPlethora Solutions Holdings Plc Regulatory News (PLE)

  • There is currently no data for PLE

AGM Statement & PSD502 Regulatory Update

1 Jul 2013 12:07

RNS Number : 2782I
Plethora Solutions Holdings PLC
01 July 2013
 



1 July 2013

 

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

AGM Statement & PSD502 Regulatory Update

 

 

Plethora Solutions Holdings plc (AIM: PLE), announces that at the Company's AGM held today Jim Mellon, Chairman, made the following statement.

 

To date in 2013 Plethora has reshaped its business and board and is focusing its entire effort on the delivery of value from PSD502 a treatment for Premature Ejaculation. Considerable progress has been made against this objective.

 

The Company can today report that it has received from the European Medicines Agency ("EMA") the Day 180 List of Outstanding Issues ("LOOI"). This formal response is in line with late stage procedures in the approval process. Based on established timelines the Company expects the decision in relation to marketing authorisation by the end of 2013, and, if granted, this would allow marketing to commence in 2014.

 

Concurrent with the approval process the Company has significantly increased its business development activities with the objective of securing one or more partners to market PSD502 not only in the EU but other territories under the Company's control. Discussions have commenced with a number of companies, however, the timeline for agreement and likely structure and quantum of any transaction is hard to determine at this stage. It is the Company's objective to secure a marketing partner before the end of 2013.

 

 

The Company announces that all resolutions set out in the notice of the AGM were passed at the meeting today.

 

 

 

-Ends-

 

Enquiries:

Plethora Solutions

Ronald Openshaw, CEO

Tel : +44(0) 20 3077 5400

Daniel Stewart (Nomad & Joint Broker)

David Hart / James Felix (Nomad)

Martin Lampshire (Broker)

Tel : +44(0) 20 7776 6550

 

Hybridan LLP (Joint Broker)

Claire Louise Noyce/ Deepak Reddy

Tel: +44(0) 20 7947 4350

 

Britton Financial PR

Tim Blackstone

Tel: + 44 (0) 20 7241 9786

+44 (0) 7957 140416

 

 

About Plethora:

 

Plethora is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk 

 

Plethora is focussed on seeking to launchPSD502 for the treatment of premature ejaculation.

 

About PSD502 & Premature Ejaculation:

PSD502 is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. The product has completed all clinical testing and has been submitted for approval in Europe with the EMA. The Company anticipates launch in late 2013 or early 2014.

 

Premature ejaculation is possibly the most common form of sexual dysfunction in men. Epidemiological studies conducted in the US and in Europe indicate a prevalence of 20 - 30% in men of all ages. There is currently no globally approved and effective pharmaceutical treatment for this condition.

 

In the absence of any widely approved pharmaceutical therapy with good patient acceptance, the premature ejaculation market offers significant potential for development and growth. An effective drug therapy for premature ejaculation may have a comparable commercial potential to the erectile dysfunction drugs.

 

 

 

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
AGMUGUQUMUPWGGG
Date   Source Headline
15th Mar 20132:57 pmRNSHolding(s) in Company
25th Feb 201311:07 amRNSStrategic review of The Urology Company Limited
14th Feb 20137:00 amRNSFinancing Update
5th Feb 201312:24 pmRNSRelated Party Transaction
5th Feb 20138:19 amRNSFinancing Update
7th Nov 20124:58 pmRNSHolding(s) in Company
28th Sep 20127:00 amRNSHalf Yearly Report
29th Jun 201211:55 amRNSReport & Accounts
29th Jun 20127:00 amRNSTotal Voting Rights
26th Jun 20125:15 pmRNSHolding(s) in Company
15th Jun 20124:11 pmRNSIssue of Equity - Directors' Interest
14th Jun 201212:05 pmRNSSubscription of Shares
24th Apr 201212:00 pmRNSChange of Registered Office
29th Mar 20127:00 amRNSPreliminary Results
15th Mar 20127:00 amRNSPSD502 Regulatory Submission Update
23rd Jan 20127:01 amRNSTrading Statement
20th Jan 20127:00 amRNSProduct Launch
6th Jan 20127:00 amRNSDirectorate Change
19th Dec 20117:00 amRNSProduct Update
31st Oct 20116:04 pmRNSTotal Voting Rights
14th Oct 20111:23 pmRNSResult of General Meeting
30th Sep 20117:00 amRNSHalf Yearly Report
28th Sep 20117:00 amRNSAmendment to PSD502 Agreements
28th Sep 20117:00 amRNSProposed Financing & Reduction of Debt
25th Jul 20117:00 amRNSStriant® SR commercial update
20th Jul 201112:09 pmRNSTrading Update
6th Jul 20111:24 pmRNSResult of AGM
24th Jun 20112:36 pmRNSReport and Accounts
20th Jun 20117:00 amRNSRe Agreement
9th Jun 201110:00 amRNSResignation of Dr Steven Powell
4th May 20117:00 amRNSExpansion of UK Sales Force
3rd May 20113:48 pmRNSTotal Voting Rights
28th Apr 20114:02 pmRNSDirector/PDMR Shareholding
28th Apr 20112:00 pmRNSHolding(s) in Company
20th Apr 20114:05 pmRNSResult of EGM
15th Apr 20117:00 amRNSHyalofemme Product Update
1st Apr 20117:00 amRNSPlacing
1st Apr 20117:00 amRNSFinal Results
14th Mar 20117:00 amRNSRe Agreement
11th Mar 20112:52 pmRNSDirectorate Change
24th Feb 201112:02 pmRNSHolding(s) in Company
3rd Feb 20119:48 amRNSDirector/PDMR Shareholding
3rd Feb 20117:00 amRNSTrading Update
28th Jan 20113:47 pmRNSHolding(s) in Company
22nd Dec 20104:42 pmRNSHolding(s) in Company
20th Dec 201010:24 amRNSResult of Meeting
20th Dec 20107:00 amRNSExpansion of Product Portfolio
3rd Dec 20107:05 amRNSBusiness Update & Proposed Placing
3rd Dec 20107:00 amRNSProduct Update
17th Nov 20107:01 amRNSLaunch of 3 New Products

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.