QRxPharma Limited (QRXPY)

[ErnieBilco]

QRx Pharma, Ltd.: Scott+Scott, Attorneys at Law, LLP Files Shareholder Class Action Against QRx Pharma, Ltd. -- QRXPY, QRXPF

Jun 23, 2015
OTC Disclosure & News Service

-

NEW YORK, June 23, 2015 (GLOBE NEWSWIRE) -- Notice is hereby given that Scott+Scott, Attorneys at Law, LLP filed a securities class action complaint against QRx Pharma, Ltd. (“QRx” or “the Company”) (OTCBB:QRXPY) (OTCBB:QRXPF) and the Company’s former Chief Executive Officer (“CEO”) John Holaday in the United States District Court for the Southern District of New York. The lawsuit alleges violations of the Securities Exchange Act of 1934 and was filed on behalf of all purchasers of QRx American Depository Receipts (“ADRs”) between January 24, 2011 and April 23, 2014, inclusive (the “Class Period”).

The complaint alleges that QRx issued false and misleading public statements and omitted material facts concerning the commercial prospects for its experiment drug Moxduo. Specifically, the complaint alleges that QRx failed to disclose to investors that it received a “no agreement letter” from the Food and Drug Administration (“FDA”) regarding its Moxduo trials and further misrepresented and concealed other material facts concerning its attempts to get Moxduo approved. Upon the disclosure of an FDA memorandum which denied QRx’s application to get Moxduo approved, the price of QRx ADRs plummeted over 83% on April 23, 2014.

You can view a copy of the complaint filed by Scott+Scott at: http://www.scott-scott.com/cnt/cp/qrx_pharma_complaint.pdf

If you purchased QRx ADRs during the Class Period, you may move the Court no later than August 24, 2015 to serve as lead plaintiff. Any member of the investor class may move the Court to serve as lead plaintiff through counsel of its choice, or may choose to do nothing and remain an absent class member. If you wish to discuss this action or have questions concerning this notice or your rights, please contact Michael Burnett, Esq. at Scott+Scott ([e-mail] [phone], [phone], or visit the Scott+Scott website, http://www.scott-scott.com) for more information. There is no cost or fee to you.

Scott+Scott is one of the leading class action law firms in the United States, with offices in New York, Connecticut, Ohio and California. The firm has been directly responsible for the recovery of hundreds of millions of dollars on behalf of its clients through the prosecution of major securities, antitrust and employee retirement plan class action lawsuits. The firm represents pension funds, foundations, individuals, businesses, and other entities worldwide.


Michael Burnett, Esq.
Scott+Scott, Attorneys at Law, LLP
[phone]
[phone]
[e-mail]

[ErnieBilco]

They are sueing the former CEO for the fraud he perped on shareholders.

[Sheep]

I got that in the mail yesterday. I was going to do some research to see what each one of them actually meant. But I most certainly plan on voting! They have run this into the ground. I really have no clue what they were thinking.

[ErnieBilco]

I voted NO on all three proxy items - if the new BOD is FOR them I'm against them.

[ErnieBilco]

Well, there doesn't seem to be anything left to help this dying ticker. Why did the note holders take it over only to trash it completely? It makes no sense to my simple mind.

[coupleofsnipes]

Friggin FDA.. Just like you said from the start. BS! But I hope you catch it.. If you think you've found it, please let us know. I'll follow you back in. You know this one pretty well. We should have known something was up yesterday when we saw a bunch of pretty sizable dumps @ .32 ugh

[ErnieBilco]

I'm in at .58 so I gotta catch a possible bottom to try and make up the losses on a bounce - IF IT GETS ONE - Today's release is pretty bleak.

[coupleofsnipes]

Sucks. I'm out with 56% loss

[ErnieBilco]

Looks like the new BOD decided to steal whatever money was there and pocket it and just get ready to BK the company.

Pretty sad - Hope they take them to the Outback and let the crocs eat their greedy lil fingers SLOWWWWWWWWWWWWWWWWWWWWWWly.

[ErnieBilco]

QRxPHARMA HALTS MOXDUO DEVELOPMENT
Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and OTCQX:
QRXPY) today announced that it is halting all further development work on the Moxduo portfolio of
products.
As announced on 26 May 2014, QRxPharma received a Complete Response Letter (CRL) from the
United States Food and Drug Administration (FDA) regarding its Moxduo New Drug Application
(NDA). Following the CRL, the Company had an End of Review (EOR) meeting with the agency on
US 9 July.
The management team has since conducted a detailed review of the MoxDuo technology with
particular emphasis on the EOR meeting with the FDA and made a recommendation to the Board to
halt all further development of the Moxduo IR, CR and IV programs. The Board of QRxPharma has
agreed with, and accepted this recommendation.
The Company believes that the Moxduo program will require a repeat Phase 2 clinical study, followed
by one or more pivotal Phase 3 clinical studies. The FDA has advised that agreement on a Special
Protocol Assessment (SPA) would be unlikely for these studies and given specific issues related to the
design of these clinical studies, such as a primary endpoint of 90% SpO2 and flexible dosing, both
which have been strongly encouraged by FDA, the likelihood of success is now in considerable doubt.
The Company estimates the time and cost for such a development program to be significant and is not
commercially justified given the limited residual patent life.
With immediate effect, the Company will be implementing a reduction in its overhead structure,
minimizing non-essential expenditure and retaining only a small core team tasked with exploring all
strategic alternatives for the Company and its assets.
The Company reported A$10.5 million in cash reserves at 30 June 2014, however as noted in the
recently filed Appendix 4C the Company has set aside in escrow A$3.62 million to cover potential
liabilities of its current employees, consultants and the former CEO arising from i) Notice
entitlements, ii) Termination payments and where applicable, iii) Retention payments. In addition, the
Company had been carrying as a liability excess annual leave entitlements. During July the Company
paid down A$0.43 million of this liability. Estimated free cash at 30 September 2014 will be
approximately A$3.0million
###
For more information please contact:
Edward M Rudnic, Ph.D.
Chief Executive Officer
Tel: [phone]
Email: [e-mail]
Chris J Campbell
Chief Financial Officer and Company Secretary
Tel: [phone]
Email: [e-mail]2
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements

[coupleofsnipes]

I'm hopping on the bid. What you said makes perfect sense. Even if you're half-right, they have at least one deep pocket investor that might shell out a few more bucks down the road if needed.

A biotechnology company that counts billionaire property magnate Lang Walker as a major shareholder, QRXPharma, has announced it is stopping work on the development of its pain medication, flagging lay-offs of staff as it reduces its company to a “small, core team”.

Sucks.. But the last team blew it. I'll give Dr.Rudnic a few months.

[Sheep]

Man I don't know. I personally do not think we will see .25 by the end of day. I think it will take many months to get back in the .30s. Though on the other hand maybe the guys who took over the company already had a plan and had been working on another deal from day one. Maybe the Moxduo decision was just a formality, and they knew what they wanted to do before the takeover.

[coupleofsnipes]

Do you think today would be a good day to add or wait/see where it shakes out? I would hate to miss 16-18's if we're going to bounce to .25 by EOD. Could be an overreaction. Things were never looking good for Moxduo.

[Sheep]

Same boat, I will just forget about this one for now. They have 12 million in cash, so my hope is the Stealth Beadlet Technology. If Moxduo is history then their whole pipeline has been closed down. The whole pipeline is moxdue variants. http://qrxpharma.com/go.cfm?do=Page.View&pid=100

[coupleofsnipes]

Only 30,000 shares traded. What do you guys think? Hold or fold?

[Sheep]

yeah, I agree. Maybe their focus will be to get the Stealth Beadlet Technology licensed out. At this point it is not worth me selling. I might have to hold this one for a couple years....


http://qrxpharma.com/go.cfm?do=Page.View&pid=100

[coupleofsnipes]

Moxduo is history. What about the rest of the pipeline? This just turned into an extra long-term hold.

[Sheep]

Just found it as well:
http://www.finnewsnetwork.com.au/archives/finance_news_network77564.html

Shares in QRxPharma Limited (ASX:QRX) have plunged more than 50 per cent on the news they will halt development of Moxduo. The pharmaceutical company announced in late May the pain drug had failed to receive approval from the US Food and Drug Administration. The company says the time and cost of further development would not be commercially justifiable. Shares in QRxPharma are trading down 50.68 per cent at $0.04

[coupleofsnipes]

A little more info as far as what they're going to do with the technology would be nice. I mean they just cleaned house!! WTF is this??

[coupleofsnipes]

Never mind I've seen it.

[Sheep]

humm, don't know what to think about that break. I bought some, but geesh.

[coupleofsnipes]

News today Ernie? I don't see anything.

[coupleofsnipes]

The only stock on ihub that has 12 mil in cash, 0 debt, stealth beadlet technology, potential beast of a product with world wide distribution ready to roll with final approval.. That has only 3 board followers lol

[coupleofsnipes]

I've been adding some also sheep. Cheers to this one being the best long term play on the board. QRXPY

[Sheep]

Well right or wrong, I went ahead and picked up some more today. I've got my ave down to .615. I don't think I will be buying any more. I do think once the new board announces the new direction for the company we could see a strong move. This is not the first time the stock price was below $1. Back in Feb of 2009 we were at .55 and by October of 2009 the stock price was at $5.50.

http://qrxpharma.com/download/file/filings/2014/QRxPharma_General_Shareholder_Update_31_July_2014_Final.pdf

[Sheep]

Hey thanks. I was on vacation last week and totally missed this.

[ErnieBilco]

ASX RELEASE
31 July 2014
GENERAL SHAREHOLDER UPDATE
Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and OTCQX:
QRXPY) today provided a brief general shareholder update following the Board changes announced
on 9 July.
Business Review
In recent weeks the new Board has been assisted and supported by the management team in closely
examining all key aspects of the business. A detailed review is currently underway, with particular
emphasis being given to the clinical development, regulatory, commercial and financial position of the
Company.
The Company expects within the next two weeks to receive the final minutes of the End of Review
(EOR) meeting regarding the Moxduo® New Drug Application (NDA), which was held with the
United States Food and Drug Administration (FDA) on 9 July. The Board and senior management
plan to meet soon thereafter to consider a range of strategic alternatives for the business. The
Company is in the process of finalising the Financial Report for the year ended 30 June 2014 and the
Board anticipates providing shareholders with a more detailed strategic and financial update by the
end of August.
Board Composition
The Board of Directors is giving careful consideration to the composition of the Board and the
optimum mix of skills and experience of Directors required for the Company at this stage. Further
appointments to the Board are anticipated in the near term.
###
For more information please contact:
Edward M Rudnic, Ph.D.
Chief Executive Officer
Tel: [phone]
Email: [e-mail]
Chris J Campbell
Chief Financial Officer and Company Secretary
Tel: [phone]
Email: [e-mail]

[Sheep]

I really thought with the newly elected board we would have heard something by now.

[ErnieBilco]

I haven't gotten any - it hit my screen when it traded 450 @ .01 - I've been bidding on and off since then.

[coupleofsnipes]

I just looked at that other one briefly. Were you able to get in on that .28 cent deal earlier this year? Do you know if they raised all the additional capital they needed? Thanks again

[ErnieBilco]

QX is the safest bet IMO. - they have 24mil in the bank - doesn't trade a lot but has huge swings when it does

[coupleofsnipes]

Thanks Ernie! Big spread on that one? I see .88. I'll do some reading tonight. I'm tired of getting crushed on all the other garbage out there. Have a good night!

[ErnieBilco]

VRACY under .50 would be a really nice buy.

[coupleofsnipes]

You see anything else out there with as much capital and potential under $1 out there?

[coupleofsnipes]

With all the dough they have in the bank, they wouldn't be doing any diluting here, would they? I made a small buy at the close for 1200.. I forgot who was on there but the ask didn't move. Thanks Ernie

[ErnieBilco]

I'm betting once the new board gets settled in we will start making some visible gains. My 1st exit is over a buck just to get my coins back and let the rest ride.

[coupleofsnipes]

Anyone else feel like we are undervalued here & one day we are going to wake up to some fantastic news? QRXPY!

[Sheep]

Man do I agree Ernie! It is just a matter of time until the weight of the US government falls in upon itself. That is why I always put some profit into metals....

Anyway, I went ahead and averaged down today. I can't say if it was the right call, but I think with the new board we should get some good PRs soon. I just think all those institutional investors that took over the company don't want to just lose their money.
I think we see a move by the company for EU approval.

[ErnieBilco]

I hope the new board will consider going for EU approval and tell the FDA to stuff it. Go wherever the process will get it approved without the FDA extortion machine collecting more and more money.

Shhhh, I;ll tell you a secret: The FDA kills more people with their approvals of bad drugs because the makers paid them off. LOOK AT THE DRUGS THAT ARE RECALLED AFTER THE FDA HAILED THEM AS "SAFE".

PLEASE QRXPY - RUN AWAY FROM THE FDA AND GO SOMEWHERE MORE AMIABLE.

[Sheep]

Bowing to pressure from disgruntled institutional shareholders, four members of QRxPharma's BOD resign, including Chairman Dr. Peter Farrell, prior to today's General Meeting of shareholders. The source of the discontent is management's failure to earn FDA approval for its lead product Moxduo, a combo analgesic of morphine and oxycodone. The NDA was filed in November 2013 but received a negative Ad Comm vote on April 22, 2014 and a subsequent thumbs down from the agency.

http://seekingalpha.com/news/1835625-four-board-members-forced-out-at-qrxpharma?uprof=45

[Sheep]

Anyone voting on this: http://qrxpharma.com/download/file/filings/2014/QRxPharma_Notice_of_General_Meeting_9_July_2014_Final.pdf

[coupleofsnipes]

HS!!! Thanks for your DD. You could have yourself a real nice winner here. I am strongly considering jumping back in. Thanks again

[ErnieBilco]

They made no efficacy determination, they simply said there wasn't enough data given.

The Agency indicated clinical information
demonstrating a clear benefit over oxycodone and morphine alone, either by efficacy, or safety,
in an appropriate patient population, is needed

[coupleofsnipes]

I agree & Ive seen it. I've worked in pharma for over 20 years. If approval came in EU first, US might follow. I've seen that before on the flip side concerning import bans. I haven't been paying close attention here.. "Address steps required"... I thought they flat out said it wasn't approved for efficacy? It had something to do with the way they filed? TY

[ErnieBilco]

Yup, but I would still rather they blow off the FDA for now and go to the EU for approval. It is about time that these bio companies begin to bypass the corrupt FDA process of "pay to play" and seek EU approvals and leave the FDA in the dust.

But nobody has ever accused me of liking what the USA has become with the corruption now being the biggest government enterprise whereas governing used to trump greed and personal gain at the expense of the taxpayer and those unfortunate people afflicted with deseases and ills and will suffer while the FDA continues to drag its feet while collecting "fees" all along the way to approval - THAT IS BUYING APPROVAL - If you don't believe me, just take a look at the drugs they approve and then after killing so many innocents they suddenly remove them from the market.

The FDA is no longer a public safety department - it is just another fleece and extortion arm of the Mafia called the US Government.

JMO

[coupleofsnipes]

Sooooo you're saying there's a chance?

[ErnieBilco]

FDA CONFIRMS REVIEW MEETING REGARDING MOXDUO®
NDA
Meeting on US 9 July to Address Steps Required for Approval of Moxduo

Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and
OTCQX: QRXPY) announced today that the United States Food and Drug Administration
(FDA) has confirmed that the “End of Review” meeting with management of the Company
will be held at 3:00pm (EDT) on 9 July 2014 in the United States to discuss the Company’s
Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain.
The FDA granted this meeting following the issue of a Complete Response Letter (CRL) last
month.
As detailed in the Company’s announcement to the ASX on 26 May 2014, the Agency stated
in the CRL that there was not sufficient evidence to support approval of Moxduo at this time.
The Agency indicated clinical information demonstrating a clear benefit over oxycodone and
morphine alone, either by efficacy, or safety, in an appropriate patient population, is needed.

###
Media Contact Information:
Lisa Fels Gavin Lower
Brightline Strategies Buchan Consulting
Tel: [phone] x110 Tel: [phone]
Email: [e-mail] Email: [e-mail]

[ErnieBilco]

1,248,450 options have expired as of June 1st

[Fr1]

@ErnieBilco I see in the next couple of moths depending on news reaching a dollar.

[ErnieBilco]

Looks like the MMs are lined up to smack it down today. I may bid cheap on some of the F ticker - more bang for my buck kinda thing.