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yeah he does play otc PDUFA plays but the last one that was this low I think was sngdx two years ago. This would have taken off if he had of played it. I gotta think that some people have been quitely adding.
I'm surprised this hadn't gotten any love on $heff's board - they're usually all over the FDA catalysts.. even OTCs when it comes to something like a PDUFA.
Earnings are expected to be released tomorrow (according to E*trade).
I think this will be an easy double + on approval. There area also additonal catalysts this year so it may actually hold some of its gains if it is approved.
JMO
Norm
Just found this page by searching $NRIFF on the Twittersphere...
NRIFF-IRQ - Biotech Due Diligence
FDA calendar
http://www.biopharmcatalyst.com/fda-calendar/
NRIFF's market cap should be 5 to 10 times higher. Even if PPS is .50, that would give us a market cap of approx $250 million. If approved, the market cap should be closer $500 million. Just consider the $8 billion a year market. Plus 2 other drugs growing revenues yoy, average annual growth yoy is close to 50%. Then the other drugs in the pipeline to boot.
Everyone should look very close and DD this company. This could be the greatest investment we will ever see.
how much do you think will go up?
I agree. This has remained under radar somehow but I expect to see more movement/volume later in week. Hoping to add a little more myself this week.
I agree. This has remained under radar somehow but I expect to see more movement/volume later in week. Hoping to add a little more myself this week.
Picked some up here EOD. Interest has to come eventually, right?
I think this a sleeping giant that just might awake when they get FDA approval on March 4th. We sure could do with some big news and FDFA approval should be just the ticket. I am long NRIFF with 100,000 shares. Cheers!
Thx Norm, I would think this has to get some attention soon! I tried to get everything updated with company to reflect everything properly.
I bought 100,000 shares and think this one should pop to around $0.15 - $0.16 area before their March 4th PDUFA. Easy double hopefully. Cheers!
great job on ibox.. pdufa 3 weeks out ... hopefully will see some movement soon
New NRIFF Investor Presentation January 2013. Cheers!
Nuvo Research Inc. Investor Presentation - January 2013
NRIFF 3rd Quarter Results - Oct. 31st, 2012. Cheers!
Nuvo_Announces_Third_Quarter_2012_Results.pdf
NUVO RESEARCH ANNOUNCES SETTLEMENT AGREEMENT WITH APOTEX IN PENNSAID® GENERIC LITIGATION
Mississauga, Ontario, Canada – January 29, 2013 – Nuvo Research Inc. (Nuvo) (TSX:NRI) announced today that it has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent infringement litigation brought by Nuvo and Nuvo’s U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex’s filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID).
Under the terms of the settlement agreement, Nuvo and Mallinckrodt granted a license to Apotex that permits Apotex, upon approval of its ANDA by the FDA, to launch its generic version of PENNSAID on a date that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first commercial shipment of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) in the United States and April 1, 2014, or earlier under certain circumstances.
PENNSAID 2% is pending approval by the FDA and is expected to be the follow-on product to original PENNSAID. PENNSAID 2% is designed to be dosed twice per day with a metered dose pump bottle. In 2012, Mallinckrodt submitted a New Drug Application (NDA) for PENNSAID 2% with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission.
About PENNSAID
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC®), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.
PENNSAID is a registered trademark of Nuvo Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
WOMAC® is a proprietary health status questionnaire. For further information visit the WOMAC® website at www.WOMAC.com.
About PENNSAID 2%
PENNSAID 2%, which is not yet approved by the FDA, is a topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is more viscous than original PENNSAID, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original PENNSAID.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company’s product portfolio includes PENNSAID, Pliaglis® and Synera®. PENNSAID, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., the Pharmaceuticals business of Covidien, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in dermatology which will be launching Pliaglis in the U.S. and E.U. in the first half of 2013. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan) in several European countries. The Company is also developing the compound WF10, for the treatment of immune related diseases.
FOR MORE INFORMATION, PLEASE CONTACT:
Nuvo Research Inc.
Email : ir@nuvoresearch.com
Website : www.nuvoresearch.com
INDICATION
PENNSAID® is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
IMPORTANT RISK INFORMATION ABOUT PENNSAID®
PENNSAID is also contraindicated in patients:
Cardiovascular Risk
• Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.
Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.
Use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).
Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
See Full Prescribing Information for additional Important Risk Information.
Forward-Looking Statements for Nuvo Research Inc.
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the Company’s Annual Report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2011. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
Talk about an undiscovered Goldmine - WOW!!!! Cheers!
NRIFF - FDA decision on March 4 and with 3 Approved Drugs = 500%++ Potential !!!
You can buy this undiscovered BIG Goldmine currently at almost all time low .This is what is called a once in a lifetime opportunity .GLTA
FDA approval for Pennsaid (Best in Class topical medication for osteoarthritis) on March 4 ,2013 . Pennsaid®: topical NSAID for osteoarthritis, partnered with Covidien for U.S., targeting $8B oral NSAID market
Pliaglis®: analgesic peelable cream, targeting global cosmetic and dermatology markets, partnered with Galderma, worldwide launch
commencing Q2 2013
Nuvo will hit profitability this year with 2 new product launches in 2Q 2013 .Annual Revenue already hits $30 M .Nasdaq Listing is planned for this year which will bring more attention to this Goldmine
Nuvo Research (NRI.TO) or (NRIFF)
Marktcap : $ 36 M
Cash: $ 12 M
New Investor Presentation
http://www.nuvoresearch.com/investor...nuary_2013.pdf
PropThink: Nuvo Research Gaining visibility; New Patent for Pennsaid 2% is Positive
Nuvo Research Inc. (TSX:NRI) announced that it obtained an additional U.S. patent for Pennsaid 2%, an improved follow-on formulation of its currently marketed Pennsaid product. Pennsaid contains the anti-inflammatory drug diclofenac, which is applied on the skin for pain conditions such as osteoarthritis of the knee. Pennsaid is currently marketed by Covidien's (NYSE:COV) pharmaceutical division Mallinkrodt, and Pennsaid 2% is undergoing FDA review for approval. The new version is a higher strength version of the product, and is formulated to increase the penetration of diclofenac through the skin to the site of pain. Importantly, the new formulation, if approved, will have patent protection out to 2028, and could become an important product for Covidien's pharmaceutical division, which is expected to be spun out to COV shareholders as a pure-play company in mid-2013. In July, Nuvo and Covidien announced that the FDA had accepted their New Drug Application (NDA) for Pennsaid 2% with a PDUFA (FDA action) date of March 4, 2013. Covidien stated that once Pennsaid 2% is approved, it expects to have the new patent listed in the FDA's Orange Book.
NRI shares remain on the radar screen, but could gain visibility on its portfolio of products for the topical treatment of pain. In addition to Covidien, the company is partnered with leading dermatology company Galderma, which is gearing up for approval and launch of Pliaglis. Pliaglis is Nuvo's topical anesthetic cream that will be marketed by Galderma for the reduction of pain associated with dermatological procedures. Several European countries have already notified Galderma that Pliaglis has been approved, and Galderma has responded to a Complete Response Letter (CRL) in the U.S. for potential FDA approval. Nuvo is also re-launching its Synera product, a topical anesthetic patch approved in the U.S. to provide pain relief for superficial dermatological procedures, and the company may seek to partner the drug in major markets. With only a $36 million market cap, shares of Nuvo Research have substantial room to run as U.S. investors become more familiar with the company
have it on watch too!
SSSSHHHH, I like it quiet. I need a couple of more weeks.
ok good! if it meets what they are looking for,where may it go?
Volume kicking in here at .08
NRIFF
I think by the end of Feb price might reach $.18 since the PDUFA is on March 04, 2013.
32 million $$ market cap,whats the potential pps with this ss?
Looks like someone is loading up here
NRIFF
And volume above average again
After Pennsaid was approved the pps fell down from 0.36 to 0.20 in a matter of days amd when Pliaglis was approved it moved to 0.06 from 0.055.
What do you mean by "hardly"?
All this is fine but even when Pennsaid was approved the first time, the share price hardly moved.... Even as recently as October 22, 2012 when Pliaglis was approved, the price hardly budged. What makes it different this time??
Pliaglis or Pennsaid?
Pliaglis is potentially (IMHO) a game changer for Nuvo. Galderma has paid about $20m for the privilege of marketing it. They must anticipate gross sales in excess of $100m within a few years.
Sales do not depend on patient afordability; insurance or medicare frugality, nor even competition.It is a unique product being marketed in the most afluent marketplace. Either Galer got it right or the carboys got real lucky, or both.
Read more at http://www.stockhouse.com/bullboards/messagedetail.aspx?p=0&m=32051097&l=0&r=0&s=NRI&t=LIST#vkmSJeD4mxUxw1WP.99
Pennsaid 2% is a better version of currently marketed Pennsaid so i think the approval chance is very high .
So based on this, do you feel Pennsaid will get approval?
FDA has approved Pliaglis after all issues resolved and Nuvo will get some milestones payments this month .
---
Mon Oct 22, 2012 8:51am EDT
By David Moskowitz
Canadian-based Nuvo Research (TSE:NRI) announced Monday morning that the FDA has approved its Pliaglis product, a unique local anesthetic designed to minimize pain during aesthetic dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. Importantly, Pliaglis is partnered with Galderma, a leading global dermatology company, and today's news is key because it demonstrates that Nuvo and its partner were able to successfully address all of the issues in the prior Complete Response Letter (CRL) issued by the FDA. The product is a topical local anesthetic cream that uses Nuvo's proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. Earlier this year, Galderma stated that several European countries have approved Pliaglis, suggesting a global launch of the product by year-end.
NRI.TO now has three approved products, two of which are backed by significant partners. Mallinkrodt, the pharmaceutical division of Covidien plc (NYSE:COV) sells Pennsaid, a topical pain cream developed by the company. A new higher strength formula, Pennsaid 2%, is undergoing FDA review with a PDUFA (FDA Action) date of March 4, 2014. Pennsaid 2% is not only designed to offer better pain relief, but it also will extend patent life of the Pennsaid franchise out to 2028. Because COV's pharmaceutical division is anticipated to be spun out as a stand-alone company in mid-2013, the marketing push behind Pennsaid, among other Mallinkrodt products, is likely to increase. Synera is NRI.TO's third approved product, which is a topical anesthetic patch approved for children and adults to numb the skin prior to needle procedures. The company is exploring strategies to increase the market uptake of this asset. As visibility for the company increases, a U.S. listing for the shares becomes a distinct possibility. Expect shares of NRI.TO to trade higher today on the news of the Pliaglis approval.
manufacturing issues ? what do you mean ? there is no manufacturing issues
Pliaglis : Tattoo removal will be a big hit
Newly Launched product Pliaglis has great Market Potential too . Pliaglis is now available in USA , Europe and other Countries will follow next Quarter .
http://vimeo.com/53863623
Pliaglis is the first and only FDA-approved topical anesthetic cream that combines the highest concentrations of two powerful ingredients, lidocaine and tetracaine, which provides safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures such as dermal filler injections, laser treatments and chemical peels.
Here is why Pennsaid will dominate the $8 Billion osteoarthritis Market !!
(Pennsaid)Topical Diclofenac Better Than Oral For Arthritis
~ i agree! ruff! /=^.^=\
do you mean this?
http://stockcharts.com/h-sc/ui?s=NRI.TO
Some nice hits coming in now, I like how well NRIFF is holding up here after a nice run the past 2 days. She's strong!
Sure looks that way Kei - if we get the volume today that we've seen over the last few days, NRIFF can supass the .13 with ease! Plus, PDUFA is in March, this could run to all new highs!
~ double digit is within reach imo ... maybe today?
NRIFF - looks like a gapper this am!
Started buying today based on company presentation and recent PR's. Took hours to fill my order at the ask.
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Nuvo is focused on increasing shareholder value by:
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Canada - Paladin Labs Inc. | |
United States - Covidien plc | |
Pennsaid Partners - Europe
Greece - Vianex S.A. | |
Italy - Italchimici | |
United Kingdom - Movianto UK | |
Pennsaid 2% Partners - Worldwide
Canada, Central & South America, South Africa & Israel - Paladin Labs Inc. | |
United States - Covidien plc | |
Pliaglis Partner
Worldwide - Galderma Pharma S.A. | |
Synera Partners
European Union and China - Eurocept International B.V. | |
Canada - Paladin Labs Inc. | |
Corporate Structure
Nuvo Research Inc. was incorporated on August 22, 1983 under the laws of the Province of Ontario as Clark Pharmaceutical Laboratories Ltd. On November 14, 1990, the articles were amended to change the name of the Company from Clark Pharmaceutical Laboratories Ltd. to Dimethaid Research Inc. On September 30, 2005, the articles were further amended to change the name of the Company from Dimethaid Research Inc. to Nuvo Research Inc. On January 1, 2007, the Company completed a short-form amalgamation with Akorn Pharmaceuticals Canada Limited, Excelpharm Inc., Femina Inc., Dimethaid Management Inc. and Dimethaid Manufacturing Inc., certain of its subsidiaries. The amalgamated entity continues as Nuvo Research Inc.
Nuvo Research Inc. has two Canadian locations. Its registered office and principal place of business is its head office located in Mississauga, Ontario. It also operates a manufacturing facility in Varennes, Quebec where it manufactures Pennsaid®.
Nuvo Manufacturing GmbH produces OXO-K993 from its manufacturing facility in Wanzleben and Leipzig based Nuvo Research GmbH (NRG) conducts and coordinates research and development activities related to WF10 in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig. NRG has received funding commitments for certain of its research and development projects from the Development Bank of Saxony.
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