QRxPharma Limited (QRXPY)

[Fr1]

You are 100% right. This will take multiple years to be an approval.

[ErnieBilco]

With the update I would expect it to drop into the 20s soon.

I wish they would forget about the FDA for now and concentrate on foreign approvals. The FDA is a crooked organized crime operation run by congressmen,senators,and government crooks who trade insider information for their own personal gains while fleecing the drug makers for "fees".

I would trust a foreign approved drug before an FDA bought approved drug. Look at how many "bad" drugs the FDA approves only to say "oops" when people die because of their incompetence.

That's my opinion, nobody has ever accused me of "holding back" on what I feel.

[Fr1]

@ErnieBilco what do U see in the near future for this company

[ErnieBilco]

ASX RELEASE
26 May 2014
QRxPHARMA RECEIVES COMPLETE RESPONSE LETTER FROM FDA
REGARDING MOXDUO® NDA
Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and OTCQX:
QRXPY) announced today the United States Food and Drug Administration (FDA) has issued a
Complete Response Letter (CRL) regarding the Moxduo New Drug Application (NDA) for the
treatment of moderate to severe acute pain. The Agency stated 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.
The Company is presently reviewing the Agency’s feedback and will request a meeting with the
FDA to clarify the steps required for approval.
“We will work with FDA to develop a clinical program that addresses the Agency’s feedback and
ensure that the completed program will clearly demonstrate Moxduo's benefit,” said Dr. Edward
Rudnic, Chief Executive Officer, QRxPharma.
###
Media Contact Information:
Lisa Fels Gavin Lower
Brightline Strategies Buchan Consulting
Tel: [phone] x110 Tel: [phone]
Email: [e-mail] Email: [e-mail]

About QRxPharma
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical
company focused on the development and commercialisation of new pain management and
abuse prevention products. The Company’s product portfolio includes both late and early stage
clinical drug candidates with the potential for reduced risks and improved patient outcomes.
QRxPharma has entered into strategic agreements with Actavis Inc., Paladin Labs Inc., Aspen
Group and Teva Pharmaceuticals for the commercialisation of immediate release Moxduo in the
US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel. The
Company’s clinical pipeline includes an intravenous (IV) and controlled release (CR)
formulation of Moxduo. QRxPharma is also collaborating with Aesica Formulation Development
Limited, for the worldwide promotion of QRxPharma’s proprietary Stealth Beadlets™ abuse
deterrence technology. For more information, visit www.qrxpharma.com.

[ccfume]

Good deal, it will go back up. Its just a matter of when. Good luck

[Sheep]

yeah if i knew were the bottom was i would not have bought today. I am just buying some here and there until I get my average down below .50. I think we have several months before it moves north. I just don't want to be caught waiting for teens when it starts to move. Today I lowered my ave from 3.28 to 1.32.

[ccfume]

I'll wait until it reaches in the teens, then I will buy. Until then it's not good trying to catch a falling knife.

[Sheep]

Alright I started averaging down today. My ave is now 1.32. Maybe next week it will sink to the .20s and I can get more.

[ErnieBilco]

I believe it is actually cheaper to get EU approval and would think more and more bios will begin their drug approvals overseas because once approved the FDA's bribery fees for US approval will drop.

How many bad drugs has the FDA allowed to be sold? They don't know any more than me or you. Its all about extortion by the beaurocraps stealing as much as they can.

JMO

I see a bounce near $1.50 to $2 near term.

[coupleofsnipes]

Thanks!

[hondaboost]

They say they'll be approved in EU, Canada and Asia. Might be bouncing to dollar.

[coupleofsnipes]

Damn.. Should have had this @ .50 this AM. They still have dough. I think I'll be averaging down. They're not dead yet, right?

[hondaboost]

Wow! QRXPY down 85% to $0.5 from $3.4, what a run!

[Sheep]

Wow ADCOM zero vote, glad i was in for only a half position.

[Sheep]

One interesting outcome of the early halt is that shorts might not have had a chance to get out. If the news is positive it could really run.

[Sheep]

Man I sure hope so. As long as the NDA goes well, which I think it should then we should be good for a nice run into the PDUFA in May.

[coupleofsnipes]

What's the consensus here amongst us 4 holders? Are we gapping up to $16 on Friday or???

[stivers10]

me too! Don't understand why they didn't just halt it on Monday if they were worried about a drop from the pre adcom papers.

[Marvy]

Too bad, I wanted to buy today

[Marvy]

Damn. I was planning on buying today

[Sheep]

A trading halt until the 24th! What the heck!

http://www.otcmarkets.com/otciq/ajax/showNewsReleaseDocumentById.pdf?id=131576958

[Sheep]

Okay back in for a half position at 3.28. I will keep a tight mental stop on this one...

[Sheep]

Well I got out yesterday in the 3.64 range for a small profit. I should have taken the profit at 4.05. Live and learn, I am surprised how quickly it cracked. It might be worth picking up some for the ad com next week.

[dbuc]

Anyone know the Adcom date?

[Sheep]

Anyone from $heff's board playing this?

[coupleofsnipes]

Glad to be one of the first mates here for this run! Going to be a nice one. Good luck to whoever else is here!

[Sheep]

2014 Company Overview
http://qrxpharma.com/download/file/cp/QRxPharma_Investor_Deck_March_2014_Final_%2814_March_2014%29.pdf

[Sheep]

A little DD:

NDA is April 22, 2014
PDUFA is May 25th 2014 http://www.biopharmcatalyst.com/fda-calendar/

The company has 17 million in cash. See page 3: http://www.otcmarkets.com/financialReportViewer?symbol=QRXPY&id=116633


Even Better From Page 3

Both Aspen and Teva will assume responsibility for all regulatory and product launch costs as well as ongoing marketing and sales efforts with respect to the above strategic collaborations.

Full writeup on Seeking Alpha
http://seekingalpha.com/article/2102433-qrxpharma-pivotal-catalysts-present-significant-near-term-upside-potential

I took a starter position today.

[Norm]

Ad com 4-22 should see some upside from here (3.80)

[TheFinalCD]

QRxPharma Announces 25 May 2014 as New PDUFA Date for MOXDUO® NDA







Print


Alert



Qrxpharma Limited (QX) (USOTC:QRXPY)
Intraday Stock Chart

Today : Wednesday 11 December 2013
Click Here for more Qrxpharma Limited (QX) Charts.

SYDNEY and BEDMINSTER, N.J., Dec. 11, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today that the United States Food and Drug Administration (FDA) has established 25 May 2014 as the new Prescription Drug User Fee Act (PDUFA) date for action on the Company's refiled New Drug Application (NDA) for immediate release MOXDUO. The FDA will schedule an Advisory Committee meeting prior to this date, and assuming approval, the Company plans to launch the product in the US in the second half of 2014.

"We are pleased that the FDA has assigned a PDUFA date indicating its timetable for evaluating the revised NDA and validated data," said Dr. John Holaday, managing director and chief executive officer, QRxPharma. "As 25 May 2014 falls on a Sunday the FDA will most likely issue the action letter on the preceding Friday being 23 May," added Holaday.

"Pending US approval, we are well prepared and poised to launch MOXDUO in the US with Actavis. Actavis' proven track record in the launching and marketing of opioid products will facilitate rapid uptake and significant sales in the US and maximise value for our shareholders."

In March 2012, QRxPharma finalised a license and option agreement with Actavis, which is a leading global specialty pharmaceutical company, for exclusive commercialisation and development rights of MOXDUO in the US.

QRxPharma refiled its NDA in late November. The revised NDA is the basis for recommencing the regulatory approval for MOXDUO for the treatment of moderate to severe acute pain, a US$2.5 billion segment of the US$8 billion spent annually on prescription opioids in the US. It also serves as the regulatory foundation for submitting MOXDUO for approval in Europe, Australia, Canada and other markets in the upcoming months. MOXDUO, an immediate release Dual Opioid® pain therapy, is a patented 3:2 fixed ratio combination of morphine and oxycodone.

About QRxPharma
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new pain management and abuse prevention products. Based on a development strategy that focuses on enhancing the clinical utility of currently approved compounds as well as bringing new products to market, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risks and improved patient outcomes. The Company's New Drug Application for its lead product candidate immediate release MOXDUO® for the treatment of acute pain, was refiled with the US Food and Drug Administration in November 2013. QRxPharma has entered into strategic agreements with Actavis Inc., Paladin Labs Inc., Aspen Group and Teva for the commercialisation of immediate release MOXDUO in the US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel. The Company's clinical pipeline includes an intravenous (IV) and controlled release (CR) formulation of MOXDUO. QRxPharma is also collaborating with Aesica Formulation Development Limited, for the worldwide promotion of QRxPharma's proprietary Stealth Beadlets™ abuse deterrence technology. For more information, visit www.qrxpharma.com.

[Soapy Bubbles]

This will take awhile to setup.