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Great News from Endo on Monday 1 Nov 2010..
[B]The Fantastic News is around the corner .THIS SLEEPING GIANT WILL AWAKE VERY SOON .Remember there is NO Insider selling , NO Dilution even after 400% increase in Share price all this indicates that much much higher Share Price and good news is coming . Patience will pay off here big time![/B]
http://www.morningstar.com/earnings/PrintTranscript.aspx?id=18732547
[B]Asa final note, we plan to begin enrolling patients in the next study of Urocidin in refractory bladder cancer during the fourth quarter. This will serve as a registration trial comparing Urocidin to Mitomycin, the current standard treatment for this condition. Urocidin is a novel treatment for bladder cancer and reflects our commitment to this therapeutic area.
I am pleased with our clinical progress and look forward to resolving our marketing applications that are pending before the FDA.[/B]
Ivan Gergel, M.D. - EVP, Research & Development: Soon AVEED, as you know we met with FDA earlier this year. We are still considering the outcome of that meeting. We are still very muchcommitted to AVEED. We believe it has a significant place to play in theworld of testosterone replacement therapy. [B]The other one, the Urocidin study, the phase III study that was just completed. We are finalizing some of the data review, but we hopefully will be able to release date for that quite shortly – from that study quite shortly.[/B]
Great News from Endo on Monday 1 Nov 2010..
[B]The Fantastic News is around the corner .THIS SLEEPING GIANT WILL AWAKE VERY SOON .Remember there is NO Insider selling , NO Dilution even after 400% increase in Share price all this indicates that much much higher Share Price and good news is coming . Patience will pay off here big time![/B]
http://www.morningstar.com/earnings/PrintTranscript.aspx?id=18732547
[B]Asa final note, we plan to begin enrolling patients in the next study of Urocidin in refractory bladder cancer during the fourth quarter. This will serve as a registration trial comparing Urocidin to Mitomycin, the current standard treatment for this condition. Urocidin is a novel treatment for bladder cancer and reflects our commitment to this therapeutic area.
I am pleased with our clinical progress and look forward to resolving our marketing applications that are pending before the FDA.[/B]
Ivan Gergel, M.D. - EVP, Research & Development: Soon AVEED, as you know we met with FDA earlier this year. We are still considering the outcome of that meeting. We are still very muchcommitted to AVEED. We believe it has a significant place to play in theworld of testosterone replacement therapy. [B]The other one, the Urocidin study, the phase III study that was just completed. We are finalizing some of the data review, but we hopefully will be able to release date for that quite shortly – from that study quite shortly.[/B]
Once investors discover this beautiful stock ,it will explode .
ompany Profile
http://www.wsw.com/webcast/rrshq18/edap/2__Slide3.JPG
Overview
http://www.wsw.com/webcast/rrshq18/edap/2__Slide5.JPG
http://www.wsw.com/webcast/rrshq18/edap/2__Slide6.JPG
Market
http://www.wsw.com/webcast/rrshq18/edap/2__Slide10.JPG
http://www.wsw.com/webcast/rrshq18/edap/2__Slide12.JPG
Upcoming Milestones
http://www.wsw.com/webcast/rrshq18/edap/2__Slide14.JPG
Financials
http://www.wsw.com/webcast/rrshq18/edap/2__Slide17.JPG
Honestly, after reading and seeing that, you would have to be nuts to sell EDAP stock below 10 dollar. This company has nowhere to go but up.
I strongly suggest any new investor visit the EDAP website found here:
Ablatherm HIFU for Prostate Cancer Treatment by EDAP VIDEO
THIS STOCK IS FLYING UNDER RADAR . FDA APPROVAL WILL PUSH THIS STOCK TO 5-7 US$ EASILY . FANTASTIC BUYING OPPORTUNITY AT CURRENT LEVELS !
EDAP is another Hot Cancer Play Like BSDM .
Edap Tms ( NASDAQ: EDAP )
Market Cap : 24 Million$
Cash : 15,8 Million$
Price : 2,20 $
Shares Out : 11,1 M <<< LOW FLOAT
EDAP Reports Publication of Long-Term Clinical Results for Largest Cohort of Ablatherm-HIFU Patients
http://finance.yahoo.com/news/EDAP-Reports-Publication-of-pz-523047653.html?x=0&.v=1
EDAP Media Interview Highlights Prostate Cancer
http://finance.yahoo.com/news/EDAP-Media-Interview-pz-896529322.html?x=0&.v=1
Positive News Coverage of EDAP's Ablatherm-HIFU treatment: "Man beats prostate cancer thanks to annual screening"
http://files.shareholder.com/downloads/EDAP/1049042728x0x404371/7BFE7B83-3399-4282-A11F-2084F81989FB/EDAP_NewsCoverage_9.21.10.pdf
EDAP Submits U.S. FDA 510(k) Application for Marketing Clearance for Sonolith i-move
http://finance.yahoo.com/news/EDAP-Submits-US-FDA-510k-pz-3864869273.html?x=0&.v=1
Press Release Source: EDAP TMS SA On Thursday August 19, 2010, 9:15 am EDT
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are actively moving forward in obtaining approval in major lithotripsy markets for our recently developed, innovative Sonolith i-move lithotripter. Our recent 510(k) application to the FDA is a clear milestone for EDAP's expansion in this field. In addition to our high-range fully integrated Sonolith I-sys lithotripter that received 510(k) marketing clearance a year ago, our compact multi-configurations Sonolith i-move device offers a wide range of urinary stones treatment options to mid-size clinics and hospitals, hence covering all lithotripsy market segments. We look forward to working with the FDA in view of approval of our Sonolith i-move, hence providing U.S. patients and physicians with the most versatile advanced treatment option."
510(k) Status Program
Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k).
Homepage
http://investor.edap-tms.com/placements.cfm
(EDAP) FDA approval within 4 Weeks ..LOW FLOAT
THIS STOCK IS FLYING UNDER RADAR . FDA APPROVAL WILL PUSH THIS STOCK TO 5-6 US$ EASILY . THIS LOW FLOAT STOCK WILL EXPLODE LIKE A NUCLEAR BOMB .
Edap Tms ( NASDAQ: EDAP )
Market Cap : 24,8 Million$
Cash : 15,8 Million$
Price : 2,25$
Shares Out : 11,1 M
http://finance.yahoo.com/news/EDAP-Submits-US-FDA-510k-pz-3864869273.html?x=0&.v=1
EDAP Submits U.S. FDA 510(k) Application for Marketing Clearance for Sonolith i-move
Press Release Source: EDAP TMS SA On Thursday August 19, 2010, 9:15 am EDT
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are actively moving forward in obtaining approval in major lithotripsy markets for our recently developed, innovative Sonolith i-move lithotripter. Our recent 510(k) application to the FDA is a clear milestone for EDAP's expansion in this field. In addition to our high-range fully integrated Sonolith I-sys lithotripter that received 510(k) marketing clearance a year ago, our compact multi-configurations Sonolith i-move device offers a wide range of urinary stones treatment options to mid-size clinics and hospitals, hence covering all lithotripsy market segments. We look forward to working with the FDA in view of approval of our Sonolith i-move, hence providing U.S. patients and physicians with the most versatile advanced treatment option."
THE RECENT PHASE 3 STUDIE IS MUCH SMALLER COMPARED TO THE PREVIOUS BIG SUCCESS PHASE 2 STUDIE .
THE CURRENT MARKET CAP OF 125 M$ IS RIDICULOUS FOR A BIG BLOCKBUSTER CANDIDATE LIKE UROCIDIN
.MY TIP IS : LOAD UP THE TRUCK BEFORE THE RESULTS IS OUT WHICH COULD HAPPEN ANY DAY NOW .
HERE IS THE FANTASTIC PHASE 2 RESULTS :
Urocidin (Bladder Cancer) Phase 3 is a small Studie with 105 Patients , only "20% complete response” required for Phase 3 success .
This DNA is quite unique in that the tumorcells, even when they try to mutate around it, are unable to induceresistance to this compound; and it's extremely safe. We have a 70%complete response rate in patients who failed other therapies, so our Phase II data, which is in the public domain, shows about 128 patients with an average complete response of about 70%. These are patients whoat the end of the study were disease-free and had really no side effectsworth noting due to the product. The patients were able to maintaintreatment, whereas without the treatments they drop out because of sideeffects, so that is our primary technology. It has been shown effectivein-vitro in the lab against many different types of cancer. In fact, wecan't find a cancer cell it doesn't kill.
Dendreon went from 1.60 to 54.06 with 143 million shares outstanding. No splits, no dilutive offerings in that time period..Bioniche (BNC.TO) has 72 million shares outstanding !!
Bioniche is expected to achieve a series of milestones this year culminating in the release of Phase III results for its bladder cancer drug and Econiche approval in 4Q10. Bioniche presents great value and home run potential with its products under development."
A $125 million market cap is ridiculous.Blockbuster Urocidin (Bladder Cancer) results coming any day now .Bioniche could hit $6+ easily with Urocidin results .Urocidin has high chance of success ,its a small study .
Strong Buy on Barchart
http://www.barchart.com/quotes//BNC.TO
3x BUY (current month)
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
Best-Rated Canadian Stocks (Oct 17, 2010)
Below are the best-rated Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). Then the average is calculated to represent the overall rating of a stock.
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy
Bioniche is expected to achieve a series of milestones this year culminating in the release of Phase III results for its bladder cancer drug and Econiche approval in 4Q10. Bioniche presents great value and home run potential with its products under development."
A $125 million market cap is ridiculous.Blockbuster Urocidin (Bladder Cancer) results coming any day now .Bioniche could hit $6+ easily with Urocidin results .Urocidin has high chance of success ,its a small study .
Strong Buy on Barchart
http://www.barchart.com/quotes//BNC.TO
3x BUY (current month)
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
Best-Rated Canadian Stocks (Oct 17, 2010)
Below are the best-rated Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). Then the average is calculated to represent the overall rating of a stock.
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy
Bioniche is expected to achieve a series of milestones this year culminating in the release of Phase III results for its bladder cancer drug and Econiche approval in 4Q10. Bioniche presents great value and home run potential with its products under development."
A $125 million market cap is ridiculous.Blockbuster Urocidin (Bladder Cancer) results coming any day now .Bioniche could hit $6+ easily with Urocidin results .Urocidin has high chance of success ,its a small study .
Strong Buy on Barchart
http://www.barchart.com/quotes//BNC.TO
3x BUY (current month)
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
Best-Rated Canadian Stocks (Oct 17, 2010)
Below are the best-rated Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). Then the average is calculated to represent the overall rating of a stock.
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy
I think the major Bladder Cancer final results will be out within 2-3 Weeks .Market Cap of 130 Mil$ is wayyy Undervalued for a 2 Billion$ Blockbuster Drug .Anything below 2 Dollar is a big gift .Patience will payoff big time . ALL THE BEST
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
re Phase 3 results coming !!Time to get in
I think the major Bladder Cancer final results will be out within 2-3 Weeks .Market Cap of 130 Mil$ is wayyy Undervalued for a 2 Billion$ Blockbuster Drug .Anything below 2 Dollar is a big gift .Patience will payoff big time . ALL THE BEST
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
Breast Cancer candidate in Phase 3
This Stock is flying under Radar ..Market Cap of 4,7 Millon$ is ridiculous .Medifocus is a once in a lifetime Opportunity .
The technology is great and I believe game changing.I think you will be suitably impressed .Always do your own DD .
Medifocus (MFS.V) or (MDFZF.PK) Canadian Stock
Market-Cap: 4,7 Mil$
Cash: 3 Mil$
Price: 0,19 $
Shares Out : 26,1 Mio...(CEO holds 5 Mil Shares)
Current News
http://www.financialpost.com/markets/news_releases/Medifocus+Announces+Breast+Cancer+Treatment+Technology+Feature/3658951/story.html
http://finance.yahoo.com/news/Medifocus-Inc-Obtains-Two-bw-1295085397.html?x=0&.v=1
Medifocus, Inc. Announces That It Has Received Approval to Initiate Its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer from the Food and Drug Administration (FDA), Investigational Device Exemption (IDE) Application
http://www.medifocusinc.com/show_company_news.php?nid=129359
Medifocus, Inc. Announces Acceptance at Two Medical Society Meetings: Posters and Oral Presentations on Past Clinical Trial Results and the Upcoming Phase III Pivotal Study will be Given
http://www.medifocusinc.com/show_company_news.php?nid=129539
Fact Sheet
http://www.medifocusinc.com/files/medifocus_fs_Oct2009.pdf
Homepage
http://www.medifocusinc.com/
Market Potential
It is projected that invasive breast cancer cases in the US will have increased to 213,000 new cases in 2006 (National Cancer Institute). This is expected to increase to 480,000 new cases a year by 2017. This market is growing dramatically as the North American population ages.
Management believes that Medifocus’ technology can be useful in the treatment of the entire range of breast cancers. The first indication, large breast cancers, represents 20% of the total incidence of breast cancer. Medifocus is initially targeting 20% of that market.
The Medifocus system will be the first-to-market with its APA solution in 2010 - 2011, when experts suggest that the rate of diagnosis of large breast tumors will reach 76,000.
re pullback is a opportunity to load up the truck
Bladder cancer phase 3 coming within 2 Weeks .market cap of 135 million dollars is ridiculous for a 2 billion dollar drug .
re pullback is a opportunity to load up the truck
Bladder cancer phase 3 coming within 2 Weeks .market cap of 135 million dollars is ridiculous for a 2 billion dollar drug .
re pullback is a opportunity to load up the truck
Bladder cancer phase 3 coming within 2 Weeks .market cap of 135 million dollars is ridiculous for a 2 billion dollar drug .
re raaallllllllllyyyyyyy
BNC.TO is very strong again ..2 dollar + coming
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Positive Phase 3 coming in a few days = next dendreon
Target is 8-10$ by year end ...
BNC.TO is very strong again ..2 dollar + coming
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Positive Phase 3 coming in a few days = next dendreon
Target is 8-10$ by year end ...
BNC.TO is very strong again ..2 dollar + coming
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
Positive Phase 3 coming in a few days = next dendreon
Target is 8-10$ by year end ...
MARKET CAP OF 130 MILLION $ IS STILL RIDICULOUS FOR THIS BEAUTIFUL COMPANY .
RELAX AND ENJOY THE RIDE TO THE FAIR VALUE LEVEL (7-10$) .STAY LONG AND BE STRONG .
THE NEXT 2-3 WEEKS WILL BE VERY VERY INTERESTING .HAVE A NICE WEEKEND ALL.
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
------------
BIONICHE GETS THE HIGHEST RATING AGAIN = STRONG BUY
http://www.nasd100.com/2010/10/best-rated-canadian-stocks-oct-17-2010.html
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy <<<<<<<<<<<<<<<BIONICHE>>>>>>>>>>>>>>
---------------------------------------
ANOTHER STRONG BUY FOR BNC
http://www.barchart.com/quotes//BNC.TO
-----------------------------------------
3 x HIGHEST RATING ON REUTERS TOO = BUY
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
------------------------------------------
MARKET CAP OF 130 MILLION $ IS STILL RIDICULOUS FOR THIS BEAUTIFUL COMPANY .
RELAX AND ENJOY THE RIDE TO THE FAIR VALUE LEVEL (7-10$) .STAY LONG AND BE STRONG .
THE NEXT 2-3 WEEKS WILL BE VERY VERY INTERESTING .HAVE A NICE WEEKEND ALL.
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
------------
BIONICHE GETS THE HIGHEST RATING AGAIN = STRONG BUY
http://www.nasd100.com/2010/10/best-rated-canadian-stocks-oct-17-2010.html
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy <<<<<<<<<<<<<<<BIONICHE>>>>>>>>>>>>>>
---------------------------------------
ANOTHER STRONG BUY FOR BNC
http://www.barchart.com/quotes//BNC.TO
-----------------------------------------
3 x HIGHEST RATING ON REUTERS TOO = BUY
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
------------------------------------------
Once the investors discover this stock ,it will explode like a supernova .
Puramed (PMBS.OB)
Market Cap 6,8 M$
Price 0,49 $
Shares Out: 13.9 M ...( 9 million shares held by insiders )
Float : 2,9 M
Presentation May 2010
http://www.puramedbioscience.com/PuraMed%20ppt-5.2010.ppt
Fact Sheet...PLEASE READ !!
http://www.puramedbioscience.com/PuraMed%20Corp%20Profile-4.2010.pdf
PuraMed BioScience, Inc. Chairman and CEO Russell Mitchell Writes to Shareholders
http://finance.yahoo.com/news/PuraMed-BioScience-Inc-pz-203664226.html?x=0&.v=1
Bid/Ask Data ..
http://www.otcmarkets.com/stock/pmbs/quote
Why Puramed Bioscience Inc. (PMBS.OB) Should Be On Your Radar
PuraMed Bioscience, Inc. is a pharmaceutical company focused on developing and marketing a line of new, non-prescription medicines. These products target major consumer health needs, including the treatment of headaches, insomnia, and general pain. The company aims launch its first retail products within six months, and then leverage that success to become a leader in the Over-the-Counter (OTC) medicine marketplace.
Although PuraMed Bioscience is entering into a competitive market, the company’s products promise to bring innovation to the industry, allowing for faster absorption into the blood stream, greater effectiveness, fewer side effects, and lower dosage requirements. The first three products the company plans to introduce include: LipiGesic M™ (for acute relief of migraine headaches), LipiGesic H™ (for acute relief of tension headaches) and LipiGesic PM™ (for insomnia).
PuraMed is already sufficiently funded via private funding and ready to move forward with the execution of its comprehensive business plan. Recently BrokerBank analyst Philip Wright, CFA initiated investment coverage of the company and has rated the company as a “speculative buy”. Wright praised the company for running on a lean basis by keeping salaries reasonable and office overhead costs extremely low.
The share structure of the stock is also attractive with only 13,329,246 shares of common stock outstanding as of last month. PuraMed is also a fully reporting company, meaning the company must be audited by a PCAOB registered public accounting firm and must comply with the requirements of Sarbanes-Oxley. These requirements allow for greater transparency and the ability to attract a larger investor audience, subsequently enhancing shareholder value and providing greater access to capital for further growth.
With a management team bringing more than 80 years of combined industry experience, a product line addressing major healthcare needs with many competitive advantages, and a well thought-out business plan, this company is well on its way to success in the multi-billion dollar OTC medicine market. Continue to watch this company as it strives to dramatically improve the quality of life for millions of Americans.
Someone bought 55k after Hour at 1,78$ on OTC .POSITIVE PHASE 3 RESULTS FOR UROCIDIN (BLADDER CANCER VACCINE) COMING .THIS NEWS WILL PUSH THIS STOCK TO 6-8$ EASILY .BNC.TO IS STILL A FANTATSIC BUYING OPPORTUNITY .
No news items to display
Recent Trades - Last 10 of 22
Time ET Ex Price Change Volume
16:18:21 Q 1.784 0.171 27,400 <<<<<
16:13:42 Q 1.784 0.171 2,400 <<<<<
16:13:03 Q 1.784 0.171 25,000 <<<<<<
15:38:48 Q 1.7122 0.0992 1,900
15:37:37 Q 1.7421 0.1291 1,000
15:37:37 Q 1.7421 0.1291 100
15:37:37 Q 1.7322 0.1192 1,000
15:37:37 Q 1.7322 0.1192 2,500
15:36:15 Q 1.7613 0.1483 1,000
15:35:47 Q 1.7714 0.1584 2,000
Good link for Investors or Newbies
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28707027&l=0&pd=0&r=0
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
UPCOMING MILESTONES 2010 <<<< THE MOST IMPORTANT YEAR IN THE HISTORY OF BIONICHE
UROCIDIN PHASE 3 RESULTS << MONSTER SP DRIVER
ECONICHE USDA APPROVAL <<ANOTHER BIG SP DRIVER
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESS PROTECTS DOWNSIDE
Bioniche has 3 businesses with diversified risk/rewardprofiles: 1)AnimalHealth, which is expected to generate $27-$28 million insales infiscal2010; 2) Human Health, with lead product, Urocidin, in Phase3testing forbladder cancer (results expected mid-2010); 3) Food Safety,withanapproved (in Canada) vaccine for reducing E. coli 0157 in cattle*****(U.S.conditional license pending) and a pipeline of othervaccines. Thecommonelement linking most of the company’s products anddevelopmentprograms isimmune stimulation.
Animal Health
We view Animal Health as a stable business and a value backstop forthehigher risk/rewardopportunities. Our estimated F2010 sales of$27-$28million would be lower Y/Yvs F2009 (sales $33 million) due mainlytoforeign exchange impact and softnessin some end markets due totheeconomic turndown. However, 2011 could be abetter year with theeconomyrecovering and potential for geographic expansionof Folltropin.
Urocidin
Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)providesthebiggest upside potential forBNC investors, with Phase 3 resultsexpectedmid-2010. MCC is a DNA/proteinisolate fromnon-pathogenicmycobacterium, phlei. Its main action is tostimulatedirectpro-apoptotic and indirect immune-mediated killing of cancercellsinpatients with non-invasive bladder cancer.
Our initial diligence suggests that Urocidin has arelatively highoverallprobability of approval, although the first of twoplanned Phase 3trialshas a moderate level of risk – the refractory patientsenrolledin thefirst Phase 3 are a “tougher-to-treat” population thanwasenrolled inPhase 2. Mitigating the risk to a degree, is the 20%completeresponse(CR) hurdle for Phase 3 – in Phase 2, patients achieveda 46.4% CRrate at26 weeks in a population that was mainly relapsed,but also includedafew naïve patients (Figure 8).
Figure8: Urocidin Phase 2 Complete Response Rate (%)
Week12 Week 26 Month 12Month 18 (for MCC 4 mg / MCC 8 mg)
27 / 46 27/ 46 32 / 64 23 / 73 (rounded %ages)
A second planned Phase 3 trial will testUrocidin head-to-head againstthecurrent standard of care, baccilusCalmette-Guerin (BCG) infirst-linetreatment, where we expect Urocidin todemonstrate betterefficacy basedon prior data, and superior safety and tolerability– BCGis a livepathogen, carrying with it risk of contamination,fatalinfection andfrequent painful bladder inflammation.
In July 2009, Bioniche licensed U.S. Urocidincommercial rights toEndoPharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-frontcashpayment of $20 million with the potential for as much as $110millioninadditional payments based on future clinical, regulatory,andcommercialmilestones. Subsequently, in February 2010, Endo exercisedan optiontolicense the remaining global commercial rights for Urocidin,payingBionichea further $8 million, and taking on the remaining Phase3development costs.Bioniche will manufacture the product and receiveatransfer price for supply.After COGS, we estimate the net toBionichewill be approximately 20%-25% ofsales. Bioniche currentlyoperates acGMP facility capable of manufacturing~35,000 Urocidin dosesannually,with plans to build a million dose facility ata cost ofapproximately$30 million (planned funding to be provided bygovernmentloans andgrants) contingent on success of the upcoming Phase 3trial.
Bladder cancer is the fourth most common cancer in men,and the ninthmostcommon in women. About 500,000 people in the U.S. currentlyhavebladdercancer, and the number of new cases each year is about 70,000(ofwhich50,000 have the non-muscle invasive form of the cancer thatiseligiblefor Urocidin treatment). Two thirds of patients (33,330)typicaldo not respondto BCG or relapse within a year. Globally, itisestimated that 80,000 bladdercancer patients become refractoryeachyear.
Based on these estimates, the global market opportunityfor Urocidininthe refractory population would be $800 million – this assumesa perdosecost of $1,000 ($21,000 for a full course of 21 doses, supportedbythe$22,000 cost for a full course of Valstar), and assumesthateachrefractory patient receives an average of 10 doses (based on25%receiving afull course and 75% receiving only the first 6inductiondoses). If the secondPhase 3 trial expands the Urocidin labelto firstline treatment, the marketopportunity would grow to theestimated 2million doses of BCG sold globallyeach year, or $2 billion.25%penetration of this market would represent $500million in annualsales,and an estimated $112.5 million in gross profit forBioniche.
Food Safety
Food Safety, the third Bioniche business, is primarilyfocusedondevelopment and commercialization of a vaccine for cattlewhichlowersthe fecal load of pathogenic 0157 E. coli bacteria. Theproductislicensed in Canada,where the primary market, upscale cattlefarms, isvery small. The company ishopeful it will receive conditionalapprovalto sell the vaccine in the U.S. this year,where there are manymorecattle farms, and a higher percentage (20% vs. 2%bymanagement’sestimate) produce upscale, branded beef.
Near-term Hurdle for Value Inflection
The key hurdle for BNC value inflection will be Phase 3Urocidinresultsexpected mid-2010. We believe there is a moderate-to-goodchanceofsuccess for this trial, and we believe with the baseAnimalHealthbusiness, that downside risk is limited.
Key risks:
Clinical risk –While we believe Urocidin has demonstratedstrongindications of superiority(safety and efficacy) vs BCG in priorclinicaltesting, the hurdle is high forthe upcoming results for thefirst Phase3 trial for the bladder cancer drug.Mitigating this risk isthe basebusiness of Bioniche, the deep-pocketedpartner for Urocidin, andourview that the long term probability of approvalof the drug is high.
Urocidin pricing - The expected pricing for Urocidin (~$1,000 perdose)is substantiallyhigher than for BCG (~$50 per dose). We believehigherpricing can bejustified, but it will be necessary to continuetodemonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower salesinF2010 vs F2009. F2011 may see an uptick on theback of bettereconomicgrowth and specific Animal Health product initiatives,and webelieveUrocidin will be the bigger driver of BNC stock in the nearterm.
rere: Someone bought 55k after Hour at 1,78$ on OTC .POSITIVE PHASE 3 RESULTS FOR UROCIDIN (BLADDER CANCER VACCINE) COMING .THIS NEWS WILL PUSH THIS STOCK TO 6-8$ EASILY .BNC.TO IS STILL A FANTATSIC BUYING OPPORTUNITY .
No news items to display
Recent Trades - Last 10 of 22
Time ET Ex Price Change Volume
16:18:21 Q 1.784 0.171 27,400 <<<<<
16:13:42 Q 1.784 0.171 2,400 <<<<<
16:13:03 Q 1.784 0.171 25,000 <<<<<<
15:38:48 Q 1.7122 0.0992 1,900
15:37:37 Q 1.7421 0.1291 1,000
15:37:37 Q 1.7421 0.1291 100
15:37:37 Q 1.7322 0.1192 1,000
15:37:37 Q 1.7322 0.1192 2,500
15:36:15 Q 1.7613 0.1483 1,000
15:35:47 Q 1.7714 0.1584 2,000
Good link for Investors or Newbies
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28707027&l=0&pd=0&r=0
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
UPCOMING MILESTONES 2010 <<<< THE MOST IMPORTANT YEAR IN THE HISTORY OF BIONICHE
UROCIDIN PHASE 3 RESULTS << MONSTER SP DRIVER
ECONICHE USDA APPROVAL <<ANOTHER BIG SP DRIVER
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESS PROTECTS DOWNSIDE
Bioniche has 3 businesses with diversified risk/rewardprofiles: 1)AnimalHealth, which is expected to generate $27-$28 million insales infiscal2010; 2) Human Health, with lead product, Urocidin, in Phase3testing forbladder cancer (results expected mid-2010); 3) Food Safety,withanapproved (in Canada) vaccine for reducing E. coli 0157 in cattle*****(U.S.conditional license pending) and a pipeline of othervaccines. Thecommonelement linking most of the company’s products anddevelopmentprograms isimmune stimulation.
Animal Health
We view Animal Health as a stable business and a value backstop forthehigher risk/rewardopportunities. Our estimated F2010 sales of$27-$28million would be lower Y/Yvs F2009 (sales $33 million) due mainlytoforeign exchange impact and softnessin some end markets due totheeconomic turndown. However, 2011 could be abetter year with theeconomyrecovering and potential for geographic expansionof Folltropin.
Urocidin
Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)providesthebiggest upside potential forBNC investors, with Phase 3 resultsexpectedmid-2010. MCC is a DNA/proteinisolate fromnon-pathogenicmycobacterium, phlei. Its main action is tostimulatedirectpro-apoptotic and indirect immune-mediated killing of cancercellsinpatients with non-invasive bladder cancer.
Our initial diligence suggests that Urocidin has arelatively highoverallprobability of approval, although the first of twoplanned Phase 3trialshas a moderate level of risk – the refractory patientsenrolledin thefirst Phase 3 are a “tougher-to-treat” population thanwasenrolled inPhase 2. Mitigating the risk to a degree, is the 20%completeresponse(CR) hurdle for Phase 3 – in Phase 2, patients achieveda 46.4% CRrate at26 weeks in a population that was mainly relapsed,but also includedafew naïve patients (Figure 8).
Figure8: Urocidin Phase 2 Complete Response Rate (%)
Week12 Week 26 Month 12Month 18 (for MCC 4 mg / MCC 8 mg)
27 / 46 27/ 46 32 / 64 23 / 73 (rounded %ages)
A second planned Phase 3 trial will testUrocidin head-to-head againstthecurrent standard of care, baccilusCalmette-Guerin (BCG) infirst-linetreatment, where we expect Urocidin todemonstrate betterefficacy basedon prior data, and superior safety and tolerability– BCGis a livepathogen, carrying with it risk of contamination,fatalinfection andfrequent painful bladder inflammation.
In July 2009, Bioniche licensed U.S. Urocidincommercial rights toEndoPharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-frontcashpayment of $20 million with the potential for as much as $110millioninadditional payments based on future clinical, regulatory,andcommercialmilestones. Subsequently, in February 2010, Endo exercisedan optiontolicense the remaining global commercial rights for Urocidin,payingBionichea further $8 million, and taking on the remaining Phase3development costs.Bioniche will manufacture the product and receiveatransfer price for supply.After COGS, we estimate the net toBionichewill be approximately 20%-25% ofsales. Bioniche currentlyoperates acGMP facility capable of manufacturing~35,000 Urocidin dosesannually,with plans to build a million dose facility ata cost ofapproximately$30 million (planned funding to be provided bygovernmentloans andgrants) contingent on success of the upcoming Phase 3trial.
Bladder cancer is the fourth most common cancer in men,and the ninthmostcommon in women. About 500,000 people in the U.S. currentlyhavebladdercancer, and the number of new cases each year is about 70,000(ofwhich50,000 have the non-muscle invasive form of the cancer thatiseligiblefor Urocidin treatment). Two thirds of patients (33,330)typicaldo not respondto BCG or relapse within a year. Globally, itisestimated that 80,000 bladdercancer patients become refractoryeachyear.
Based on these estimates, the global market opportunityfor Urocidininthe refractory population would be $800 million – this assumesa perdosecost of $1,000 ($21,000 for a full course of 21 doses, supportedbythe$22,000 cost for a full course of Valstar), and assumesthateachrefractory patient receives an average of 10 doses (based on25%receiving afull course and 75% receiving only the first 6inductiondoses). If the secondPhase 3 trial expands the Urocidin labelto firstline treatment, the marketopportunity would grow to theestimated 2million doses of BCG sold globallyeach year, or $2 billion.25%penetration of this market would represent $500million in annualsales,and an estimated $112.5 million in gross profit forBioniche.
Food Safety
Food Safety, the third Bioniche business, is primarilyfocusedondevelopment and commercialization of a vaccine for cattlewhichlowersthe fecal load of pathogenic 0157 E. coli bacteria. Theproductislicensed in Canada,where the primary market, upscale cattlefarms, isvery small. The company ishopeful it will receive conditionalapprovalto sell the vaccine in the U.S. this year,where there are manymorecattle farms, and a higher percentage (20% vs. 2%bymanagement’sestimate) produce upscale, branded beef.
Near-term Hurdle for Value Inflection
The key hurdle for BNC value inflection will be Phase 3Urocidinresultsexpected mid-2010. We believe there is a moderate-to-goodchanceofsuccess for this trial, and we believe with the baseAnimalHealthbusiness, that downside risk is limited.
Key risks:
Clinical risk –While we believe Urocidin has demonstratedstrongindications of superiority(safety and efficacy) vs BCG in priorclinicaltesting, the hurdle is high forthe upcoming results for thefirst Phase3 trial for the bladder cancer drug.Mitigating this risk isthe basebusiness of Bioniche, the deep-pocketedpartner for Urocidin, andourview that the long term probability of approvalof the drug is high.
Urocidin pricing - The expected pricing for Urocidin (~$1,000 perdose)is substantiallyhigher than for BCG (~$50 per dose). We believehigherpricing can bejustified, but it will be necessary to continuetodemonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower salesinF2010 vs F2009. F2011 may see an uptick on theback of bettereconomicgrowth and specific Animal Health product initiatives,and webelieveUrocidin will be the bigger driver of BNC stock in the nearterm.
Someone bought 55k after Hour at 1,78$ on OTC .POSITIVE PHASE 3 RESULTS FOR UROCIDIN (BLADDER CANCER VACCINE) COMING .THIS NEWS WILL PUSH THIS STOCK TO 6-8$ EASILY .BNC.TO IS STILL A FANTATSIC BUYING OPPORTUNITY .
No news items to display
Recent Trades - Last 10 of 22
Time ET Ex Price Change Volume
16:18:21 Q 1.784 0.171 27,400 <<<<<
16:13:42 Q 1.784 0.171 2,400 <<<<<
16:13:03 Q 1.784 0.171 25,000 <<<<<<
15:38:48 Q 1.7122 0.0992 1,900
15:37:37 Q 1.7421 0.1291 1,000
15:37:37 Q 1.7421 0.1291 100
15:37:37 Q 1.7322 0.1192 1,000
15:37:37 Q 1.7322 0.1192 2,500
15:36:15 Q 1.7613 0.1483 1,000
15:35:47 Q 1.7714 0.1584 2,000
Good link for Investors or Newbies
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28707027&l=0&pd=0&r=0
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
UPCOMING MILESTONES 2010 <<<< THE MOST IMPORTANT YEAR IN THE HISTORY OF BIONICHE
UROCIDIN PHASE 3 RESULTS << MONSTER SP DRIVER
ECONICHE USDA APPROVAL <<ANOTHER BIG SP DRIVER
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESS PROTECTS DOWNSIDE
Bioniche has 3 businesses with diversified risk/rewardprofiles: 1)AnimalHealth, which is expected to generate $27-$28 million insales infiscal2010; 2) Human Health, with lead product, Urocidin, in Phase3testing forbladder cancer (results expected mid-2010); 3) Food Safety,withanapproved (in Canada) vaccine for reducing E. coli 0157 in cattle*****(U.S.conditional license pending) and a pipeline of othervaccines. Thecommonelement linking most of the company’s products anddevelopmentprograms isimmune stimulation.
Animal Health
We view Animal Health as a stable business and a value backstop forthehigher risk/rewardopportunities. Our estimated F2010 sales of$27-$28million would be lower Y/Yvs F2009 (sales $33 million) due mainlytoforeign exchange impact and softnessin some end markets due totheeconomic turndown. However, 2011 could be abetter year with theeconomyrecovering and potential for geographic expansionof Folltropin.
Urocidin
Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)providesthebiggest upside potential forBNC investors, with Phase 3 resultsexpectedmid-2010. MCC is a DNA/proteinisolate fromnon-pathogenicmycobacterium, phlei. Its main action is tostimulatedirectpro-apoptotic and indirect immune-mediated killing of cancercellsinpatients with non-invasive bladder cancer.
Our initial diligence suggests that Urocidin has arelatively highoverallprobability of approval, although the first of twoplanned Phase 3trialshas a moderate level of risk – the refractory patientsenrolledin thefirst Phase 3 are a “tougher-to-treat” population thanwasenrolled inPhase 2. Mitigating the risk to a degree, is the 20%completeresponse(CR) hurdle for Phase 3 – in Phase 2, patients achieveda 46.4% CRrate at26 weeks in a population that was mainly relapsed,but also includedafew naïve patients (Figure 8).
Figure8: Urocidin Phase 2 Complete Response Rate (%)
Week12 Week 26 Month 12Month 18 (for MCC 4 mg / MCC 8 mg)
27 / 46 27/ 46 32 / 64 23 / 73 (rounded %ages)
A second planned Phase 3 trial will testUrocidin head-to-head againstthecurrent standard of care, baccilusCalmette-Guerin (BCG) infirst-linetreatment, where we expect Urocidin todemonstrate betterefficacy basedon prior data, and superior safety and tolerability– BCGis a livepathogen, carrying with it risk of contamination,fatalinfection andfrequent painful bladder inflammation.
In July 2009, Bioniche licensed U.S. Urocidincommercial rights toEndoPharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-frontcashpayment of $20 million with the potential for as much as $110millioninadditional payments based on future clinical, regulatory,andcommercialmilestones. Subsequently, in February 2010, Endo exercisedan optiontolicense the remaining global commercial rights for Urocidin,payingBionichea further $8 million, and taking on the remaining Phase3development costs.Bioniche will manufacture the product and receiveatransfer price for supply.After COGS, we estimate the net toBionichewill be approximately 20%-25% ofsales. Bioniche currentlyoperates acGMP facility capable of manufacturing~35,000 Urocidin dosesannually,with plans to build a million dose facility ata cost ofapproximately$30 million (planned funding to be provided bygovernmentloans andgrants) contingent on success of the upcoming Phase 3trial.
Bladder cancer is the fourth most common cancer in men,and the ninthmostcommon in women. About 500,000 people in the U.S. currentlyhavebladdercancer, and the number of new cases each year is about 70,000(ofwhich50,000 have the non-muscle invasive form of the cancer thatiseligiblefor Urocidin treatment). Two thirds of patients (33,330)typicaldo not respondto BCG or relapse within a year. Globally, itisestimated that 80,000 bladdercancer patients become refractoryeachyear.
Based on these estimates, the global market opportunityfor Urocidininthe refractory population would be $800 million – this assumesa perdosecost of $1,000 ($21,000 for a full course of 21 doses, supportedbythe$22,000 cost for a full course of Valstar), and assumesthateachrefractory patient receives an average of 10 doses (based on25%receiving afull course and 75% receiving only the first 6inductiondoses). If the secondPhase 3 trial expands the Urocidin labelto firstline treatment, the marketopportunity would grow to theestimated 2million doses of BCG sold globallyeach year, or $2 billion.25%penetration of this market would represent $500million in annualsales,and an estimated $112.5 million in gross profit forBioniche.
Food Safety
Food Safety, the third Bioniche business, is primarilyfocusedondevelopment and commercialization of a vaccine for cattlewhichlowersthe fecal load of pathogenic 0157 E. coli bacteria. Theproductislicensed in Canada,where the primary market, upscale cattlefarms, isvery small. The company ishopeful it will receive conditionalapprovalto sell the vaccine in the U.S. this year,where there are manymorecattle farms, and a higher percentage (20% vs. 2%bymanagement’sestimate) produce upscale, branded beef.
Near-term Hurdle for Value Inflection
The key hurdle for BNC value inflection will be Phase 3Urocidinresultsexpected mid-2010. We believe there is a moderate-to-goodchanceofsuccess for this trial, and we believe with the baseAnimalHealthbusiness, that downside risk is limited.
Key risks:
Clinical risk –While we believe Urocidin has demonstratedstrongindications of superiority(safety and efficacy) vs BCG in priorclinicaltesting, the hurdle is high forthe upcoming results for thefirst Phase3 trial for the bladder cancer drug.Mitigating this risk isthe basebusiness of Bioniche, the deep-pocketedpartner for Urocidin, andourview that the long term probability of approvalof the drug is high.
Urocidin pricing - The expected pricing for Urocidin (~$1,000 perdose)is substantiallyhigher than for BCG (~$50 per dose). We believehigherpricing can bejustified, but it will be necessary to continuetodemonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower salesinF2010 vs F2009. F2011 may see an uptick on theback of bettereconomicgrowth and specific Animal Health product initiatives,and webelieveUrocidin will be the bigger driver of BNC stock in the nearterm.
re BNC.TO HITS NEW 3 YEAR HIGH
STILL WAYYYYYYYY UNDERVALUED
THE RUNUP HAS JUST BEGUN ...ENJOY THE RIDE TO $10+ !!
POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $5-6 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC
Bioniche Life Sciences (BNC.TO)
Market Cap: 120 Mil$
Cash: 22 Mil $
Price: 1,60 $
CHECK IT OUT
http://www.rttnews.com/Content/TopStories.aspx?Id=1421944
****** BUY RATING BY DUNDEE SEC ******
Bionichehas three businesses with diversified risk/reward profiles:AnimalHealth, which is expected to generate around $28 million in salesinfiscal 2010; Human Health, with Phase 3 results expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety,with Canadian approval and a conditional license pending in theU.S. of avaccine for reducing E. coli 0157 in cattle feces, and apipeline ofother vaccines.
Mr. Martin points out that Urocidin provides the“biggest upside potential” for Bioniche investors. His initial diligencesuggests that Urocidin has a “relatively high overall probability ofapproval,” eventhough the first of two planned Phase 3 trials has amoderate level ofrisk, as the refractory patients enrolled in the trialare a“tougher-to-treat” population than was enrolled in the Phase 2trial, hesays.
Mitigating the risk somewhat is the 20% “completeresponse” hurdlerequired for Phase 3. That compares with the company’sPhase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in apopulation thatwas mainly relapsed but also included a few patientsbeing treated forthe first time.
A second planned Phase 3 trialwill test Urocidin head-to-head againstthe current standard of care,baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expectUrocidin to demonstrate betterefficacy, based on prior data, andsuperior safety and tolerability,” hepredicts.
In 2009, Bionichelicensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Basedon incidence of bladder cancer and possiblepricing, he figures theglobal market opportunity for Urocidin in therefractory population couldbe $800 million. If the second Phase 3 trialexpands the Urocidin labelto first-line treatment, the marketopportunity could grow to anestimated $2 billion.
“Twenty-five percent penetration of thismarket would represent $500million in annual sales and an estimated$112.5 million in gross profitfor Bioniche,” Mr. Martin says .
-------------------------------------------------
Chief Medical Officer exercise his option for 130000$ =MEANS HE KNOWS THAT PHASE 3 RESULTS IS VERY GOOD !!!
FilingDate Transaction Date Insider Name Ownership Type Securities Nature oftransaction # or value acquired or disposed of Unit Price
Sep 20/10 Sep 20/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 50,000 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000
.90
THE RUNUP HAS JUST BEGUN ...ENJOY THE RIDE TO $10+ !!
POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $5-6 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC
Bioniche Life Sciences (BNC.TO)
Market Cap: 120 Mil$
Cash: 22 Mil $
Price: 1,60 $
CHECK IT OUT
http://www.rttnews.com/Content/TopStories.aspx?Id=1421944
****** BUY RATING BY DUNDEE SEC ******
Bionichehas three businesses with diversified risk/reward profiles:AnimalHealth, which is expected to generate around $28 million in salesinfiscal 2010; Human Health, with Phase 3 results expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety,with Canadian approval and a conditional license pending in theU.S. of avaccine for reducing E. coli 0157 in cattle feces, and apipeline ofother vaccines.
Mr. Martin points out that Urocidin provides the“biggest upside potential” for Bioniche investors. His initial diligencesuggests that Urocidin has a “relatively high overall probability ofapproval,” eventhough the first of two planned Phase 3 trials has amoderate level ofrisk, as the refractory patients enrolled in the trialare a“tougher-to-treat” population than was enrolled in the Phase 2trial, hesays.
Mitigating the risk somewhat is the 20% “completeresponse” hurdlerequired for Phase 3. That compares with the company’sPhase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in apopulation thatwas mainly relapsed but also included a few patientsbeing treated forthe first time.
A second planned Phase 3 trialwill test Urocidin head-to-head againstthe current standard of care,baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expectUrocidin to demonstrate betterefficacy, based on prior data, andsuperior safety and tolerability,” hepredicts.
In 2009, Bionichelicensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Basedon incidence of bladder cancer and possiblepricing, he figures theglobal market opportunity for Urocidin in therefractory population couldbe $800 million. If the second Phase 3 trialexpands the Urocidin labelto first-line treatment, the marketopportunity could grow to anestimated $2 billion.
“Twenty-five percent penetration of thismarket would represent $500million in annual sales and an estimated$112.5 million in gross profitfor Bioniche,” Mr. Martin says .
-------------------------------------------------
Chief Medical Officer exercise his option for 130000$ =MEANS HE KNOWS THAT PHASE 3 RESULTS IS VERY GOOD !!!
FilingDate Transaction Date Insider Name Ownership Type Securities Nature oftransaction # or value acquired or disposed of Unit Price
Sep 20/10 Sep 20/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 50,000 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000
.90
THE RUNUP HAS JUST BEGUN ...ENJOY THE RIDE TO $10+ !!
POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $5-6 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC
Bioniche Life Sciences (BNC.TO)
Market Cap: 120 Mil$
Cash: 22 Mil $
Price: 1,60 $
CHECK IT OUT
http://www.rttnews.com/Content/TopStories.aspx?Id=1421944
****** BUY RATING BY DUNDEE SEC ******
Bionichehas three businesses with diversified risk/reward profiles:AnimalHealth, which is expected to generate around $28 million in salesinfiscal 2010; Human Health, with Phase 3 results expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety,with Canadian approval and a conditional license pending in theU.S. of avaccine for reducing E. coli 0157 in cattle feces, and apipeline ofother vaccines.
Mr. Martin points out that Urocidin provides the“biggest upside potential” for Bioniche investors. His initial diligencesuggests that Urocidin has a “relatively high overall probability ofapproval,” eventhough the first of two planned Phase 3 trials has amoderate level ofrisk, as the refractory patients enrolled in the trialare a“tougher-to-treat” population than was enrolled in the Phase 2trial, hesays.
Mitigating the risk somewhat is the 20% “completeresponse” hurdlerequired for Phase 3. That compares with the company’sPhase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in apopulation thatwas mainly relapsed but also included a few patientsbeing treated forthe first time.
A second planned Phase 3 trialwill test Urocidin head-to-head againstthe current standard of care,baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expectUrocidin to demonstrate betterefficacy, based on prior data, andsuperior safety and tolerability,” hepredicts.
In 2009, Bionichelicensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Basedon incidence of bladder cancer and possiblepricing, he figures theglobal market opportunity for Urocidin in therefractory population couldbe $800 million. If the second Phase 3 trialexpands the Urocidin labelto first-line treatment, the marketopportunity could grow to anestimated $2 billion.
“Twenty-five percent penetration of thismarket would represent $500million in annual sales and an estimated$112.5 million in gross profitfor Bioniche,” Mr. Martin says .
-------------------------------------------------
Chief Medical Officer exercise his option for 130000$ =MEANS HE KNOWS THAT PHASE 3 RESULTS IS VERY GOOD !!!
FilingDate Transaction Date Insider Name Ownership Type Securities Nature oftransaction # or value acquired or disposed of Unit Price
Sep 20/10 Sep 20/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 50,000 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000
.90
Still time to get in cheap
Major Partner deal coming very soon ..
CLSN IS READY TO EXPLODE ....
Celsion breaks above the 200DMA at $3.56 means MAJOR RUNUP TO NEW 52W IS COMING .. VERY BULLISH SIGN
http://stockcharts.com/charts/gallery.html?CLSN
Insider Roster ..Shares Out : 12,2 M // 6,05 Mil shares held by Insiders !!!!
[url=http://www.j3sg.com/Reports/Stock-Insider/xxxgen.php?tickerLookUp=CLSN&sortBy=date_D&descending=1]CLSN : Insider Roster for Celsion Corp | J3SG[/url]
Key Events 2010
•
Sign 2nd license agreement for ThermoDox 2010 [B]<<<<< COMING ANY DAY NOW[/B]
•
600 patients in Phase III HCC Trial Q4 10
•
Complete Phase I Dignity Trial Q4 10
Enjoy the Ride .GL
BREAKOUT IS COMING
2 Blockbuster on Market within 2 years !!
Short Interest is going down again indicates that good news is on the way ...
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?symbol=CLSN&symbol=CSN&selected=CLSN
Celsion will have 2 Potential Blockbuster on Market within 2 years .Market Cap of 43 Mil$ is wayyy Undervalued .
Near Term Commercialization Potential
Liver Cancer
•
Phase III HCC Study agreed to under SPA guidance
•
Supported by 10 Regulatory Agencies including Japan and China
•
60%+ enrolled with potential to complete enrollment in 2010
•
Accelerated endpoint of PFS
•
Fast Track applied for, rolling NDA filing anticipated for 2011
Breast Cancer
Phase I/II recurrent chest wall breast cancer agreed with FDA as a potential pivotal study; gateway to superficial disease
•
Combines ThermoDox with hyperthermia for refractory patients
•
Clinical benefit is local control
•
NDA filing 2012
Commercialization plans maximize shareholder value
•
US strategy is to market and sell directly
•
Ex-US strategy is through license agreements with Pharma partners
Key Events
•
Sign 2nd license agreement for ThermoDox 2010
•
600 patients in Phase III HCC Trial Q4 10
•
Complete Phase I Dignity Trial Q4 10
Another good day for CLSN
THIS STOCK WILL BE AT 8-10$ BY YEAR END ..
Summary ..HOT PICK
The technology is great and I believe game changing . I think you will be suitably impressed .ALWAYS DO YOUR OWN DD !!!!
Thermodox Phase III results is coming very soon .Thermodox has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
The current Market cap of 43 Million$ is too ridiculous for a BIG BLOCKBUSTER .
Celsion (CLSN)
Market Cap : 43 Mil$
Cash : 5,68 Mil$ (+Celsion Corporation Secures $15 Million)
Price : 3,50 $
Shares Out : 12,27 M
Insider Activity
http://www.secform4.com/insider-trading/749647.htm
CEO LETTER ...
http://www.celsion.com/letter.cfm
From R&R Presentation:: WATCH
THERMODOX TIMELINE
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide5.JPG
MARKET POTENTIAL
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide7.JPG
Commercialization Plans
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide8.JPG
THERMODOX
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide12.JPG
UPCOMING MILESTONES
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide22.JPG
Data Monitoring Committee Unanimously Recommends Continuation of Celsion's Phase III ThermoDox(R) HEAT Study to Treat Primary Liver Cancer
http://www.celsion.com/releasedetail.cfm?ReleaseID=512752
Celsion Receives Fast Track Designation for ThermoDox(R) Development Program to Treat Primary Liver Cancer
http://www.celsion.com/releasedetail.cfm?ReleaseID=501947
Presentation Juni 2010
http://www.celsion.com/common/download/download.cfm?companyid=CLN&fileid=381216&filekey=91f619e7-1d31-4b06-9165-6b2001e1b2f2&filename=Needham%20Presentation%20FINAL%2006-09-2010.pdf
"We continue to make substantial progress recruiting patients into our Phase III HEAT trial for ThermoDox(R). We continue to track well against our goal to complete enrollment by the end of this year," said Michael Tardugno, President and CEO of Celsion. "We have exceeded our goal of opening enrollment at 70 clinical trial sites with 74 enrolling world-wide. The Phase I/II DIGNITY trial of ThermoDox(R) in patients with recurrent chest wall breast cancer (RCW) also continues to advance. We are currently enrolling patients in the 50mg/m2 dosing cohort, which will be used to determine our therapeutic dose."
RALLLYYYYYYYYYYYYYYYYYYY
CLSN IS STILL A FANTASTIC BUYING OPPORTUNITY ...
Major Breakout is coming ..Load up the truck while its very very cheap .Market Cap of 42 Mil$ is a BIG GIFT for a Blockbuster in Phase 3 .Fair Value is $7-10 !!
http://de_de.www.smallcapnetwork.com/Stocks-to-Watch-on-Friday-What-to-Watch-For-CLSN-RTK-DRWI/s/article/view/p/mid/2/id/320/
Anyway, what I'm looking for from here is a sustainable move above the 200-day moving average at $3.55. Though technical analysis 'standards' don't apply quite as well when the float's as small as it is for Celsion Corporation, in this case we can see the 200-day average has been a factor. If it's broken as a ceiling, I'm looking for CLSN to repeat the March/April move.
--
http://www.medicalnewstoday.com/articles/203135.php
Article Date: 01 Oct 2010
Data Monitoring Committee Unanimously Recommends Continuation Of Celsion's Phase III ThermoDox® HEAT Study To Treat Primary Liver Cancer
Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study
UP UP AND AWAY
STILL WAYYYY UNDERVALUED
THIS STOCK WILL BE A BILLION DOLLAR COMPANY IN THE VERY NEAR FUTURE !
http://www.fiercedrugdelivery.com/story/celsions-thermodox-liver-cancer-trials-get-fast-tracked/2010-08-25
Celsion's ThermoDox liver cancer trials get fast-tracked
August 25, 2010 — 1:02am ET | By Howard Lovy
Drug developer Celsion and sufferers of primary liver cancer received some good news from the FDA this week as the Columbia, MD-based company's first drug, ThermoDox, was granted fast-track status.
Developed in partnership with Duke University, Celsion's technology involves low heat-activated liposomes, which the company says enables delivery of drugs directly to cancer sites. They call them lysolipid thermally sensitive liposomes (LTSL), and they're being billed by Celsion as "the first in a new generation of liposomes." ThermoDox, enhanced with LTSL, treats primary liver cancer and recurrent chest wall breast cancer.
The specially treated liposomes concentrate at the tumor as an external microwave device gently heats the tumor tissue to 42 degrees Celsius over the course of 40 minutes. ThermoDox circulates through the bloodstream, penetrating tumors through vascular leaks. The microwave heat accentuates this leaking, opening the tumor door to more ThermoDox. According to the company, the liposome "melts" only when the microwave heat is present and releases the oncology drug doxorubicin only into the tumor in high concentrations.
Celsion says its goal is to improve standard treatment options for difficult-to-treat cancers, including non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. For liver cancer, the technique is used in conjunction with radio frequency ablation (RFA), which uses uses extremely high temperatures of 80 to 100 degrees Celsius to ablate tumors. RFA may fail to treat the outer margins of larger tumors since temperatures in the periphery are not high enough to destroy the cancer cells. That's where ThermoDox comes in.
"We are very pleased to receive the Agency's Fast-Track Designation for ThermoDox," says CEO Michael Tardugno, in a statement. "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease."
ThermoDox is currently being evaluated under a Special Protocol Assessment agreement with the FDA in a 600-patient global Phase III trial in patients with primary liver cancer. Celsion hopes to complete patient enrollment by the end of the year.
After BSDM now CLSN = 10 BAGGER
THE NEXT HYPE WILL START HERE ...
The technology is great and I believe game changing . I think you will be suitably impressed .ALWAYS DO YOUR OWN DD !!!!
Thermodox Phase III results coming .Thermodox has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
Market cap of 37 Mil$ is significantly undervalued for a BIG BLOCKBUSTER !!
Celsion (CLSN)
Market Cap : 37,4 Mil$
Cash : 5,68 Mil$ (+Celsion Corporation Secures $15 Million)
Price : 3,05 $
Shares Out : 12,27 M <<< LOW FLOAT
Insider Acitivity
http://finance.yahoo.com/q/it?s=CLSN+Insider+Transactions
From R&R Presentation:: WATCH
THERMODOX TIMELINE
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide5.JPG
MARKET POTENTIAL
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide7.JPG
Commercialization Plans
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide8.JPG
THERMODOX
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide12.JPG
UPCOMING MILESTONES
http://www.wsw.com/webcast/rrshq18/clsn/2__Slide22.JPG
"We continue to make substantial progress recruiting patients into our Phase III HEAT trial for ThermoDox(R). We continue to track well against our goal to complete enrollment by the end of this year," said Michael Tardugno, President and CEO of Celsion. "We have exceeded our goal of opening enrollment at 70 clinical trial sites with 74 enrolling world-wide. The Phase I/II DIGNITY trial of ThermoDox(R) in patients with recurrent chest wall breast cancer (RCW) also continues to advance. We are currently enrolling patients in the 50mg/m2 dosing cohort, which will be used to determine our therapeutic dose."