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SIA-Chart on VPHM : Very Bullish : Besides having a superman show up, which happens when the stock goes 5% above its 100 day moving average. We also have a super cross show up which means that the 50 day moving average has broken above the 100 day moving average, which is also very bullish and means that buyers are coming in big time.
THIS IS THE NEXT BIG MONSTER STOCK ..READ WHY
This is a real unknown gem ,once investors discover this stock it will explode like a nuclear bomb .LOAD UP THE TRUCK WHILE YOU STILL CAN BECAUSE ITS TRADING SIGNIFCANTLY BELOW CASH LEVEL !!
NDA filing for Blockbuster Marqibo next quarter and it could be approved before the end of this Year .
MARKET CAP OF 10 MILLION MAKES ME A BIG LAUGH // TLON WILL MOVE INTO DOUBLE DIGITS IN THE COMING MONTHS (As an example 10$ per share means 270 Mil Market Cap even at 10$ A BIG JOKE !!
Talon Therapeutics (TLON.OB)
Market Cap: $10,4 Mil
Cash: 27,2 Mil
Price : 0.48 $
Shares Out: 21,2 Mil
New Presentation // A MUST READ !!
http://www.talontx.com/pdf/talontx_corp_pres.pdf
Marqibo® is poised for accelerated approval in 4Q 2011
NDA submission and request for priority revue expected in 2Q 2011
Sought indica<on =Adult Ph(--)ALL in 2nd relapse or that has failed 2lines of Rx
35% overall response rate as 3rd-6th line treatment in RALLY study
20% complete response rate with impressive median dura<on and survival
.................
http://biotuesdays.com/2011/02/01/talon-to-seek-accelerated-approval-of-marqibo/
Talon Therapeutics (OTCBB:TLON) plans to submit a new drug application with the FDA for priority review of its Marqibo oncology drug in the second quarter this year and is hoping for accelerated approval in the final quarter of the year.
“We are seeking accelerated approval based on data from our Phase 2 RALLY study where we demonstrated a 35% overall response rate using single agent Marqibo as third, fourth, fifth or sixth line treatment,” CEO Dr. Steven Deitcher says in an exclusive interview with BioTuesdays.com. “This is the most heavily pretreated and advanced Acute Lymphoblastic Leukemia (ALL) population that has ever been described or studied in the literature.”
If Marqibo is cleared by the FDA for use in additional, larger indications, Talon is looking at a multibillion-dollar potential
The offering ($1,50 per Share) creates a great buying Opportunity .Now we know that Urocidin definitely works in Bladder Cancer means this is the next Blockbuster . Market-cap of 125 million$ is wayyy undervalued .Offering will be complete in mid December and the Rally will continue .This Stock is still under Radar .
This is a once in a lifetime Opportunity .
Upcoming Milestones:
Start of the Global Phase 3 Study in 2010 << trigger a Milestone payment from Endo
Econiche approval in early 2011 (jan or feb) << Major share price driver
INVESTMENT HIGHLIGHTS
• With the recent positive results from Urocidin™’s bladder cancer Phase III
trial, Bioniche’s co-developer, Endo, has committed to invest considerable
financial and other corporate resources to an expanded bladder
cancer programme.
• Endo will commence a large, multi-country, multi-centre additional
clinical trial in refractory patients to gain registration of Urocidin™ in
the USA and Canada.
• Urocidin™ is expected to address a material unmet need in the treatment
of bladder cancer where the current standard of care, BCG, dates
back over 30 years and, the Company believes, has issues with respect
to its efficacy, safety and tolerability.
• Bioniche has invested more than 10 years and approximately C$130 million
in bringing the Urocidin™ technology to its current stage.
• The Animal Health division provides the Company with ongoing cash
flow and is a world market leader in a number of its product offerings.
• With full licensing approval in Canada, the Food Safety division has
developed the world’s first fully licensed cattle vaccine designed to
reduce the E. coli O157 infection rates in humans resulting from consumption
of contaminated beef products, as well as infections related
to exposure to contaminated water and produce.
• The Company is currently investing in the development of other food
safety vaccines including a vaccine to prevent Salmonella in swine,
cattle and chickens.
PHASE 3 SUCCESS IN BLADDER CANCER YIPPIIIIIIIIII
PHASE 3 SUCCESS FOR BIONICHE (BNC.TO) .LOAD UP THE TRUCK WE HAVE A HUGE WINNER HERE .MARKET CAP OF 120 MIL$ IS RIDICULOUS .
BNC.TO WILL BE THE NEXT BIG CASH COW .
http://finance.yahoo.com/news/UrocidinTM-Phase-III-Trial-prnews-3143154188.html?x=0&.v=11
Urocidin(TM) Phase III Trial Results Trigger Milestone Payment to Bioniche from Endo
The current milestone payment was triggered by Urocidin™ attaining a contractual efficacy goal from an ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial. Urocidin™ is a product for non-muscle-invasive bladder cancer that is refractory to current first-line therapy. The clinical trial providing results was initiated in late 2006, prior to the execution of the agreement between the parties.
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]
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 $6+ easily with Urocidin results .Urocidin has high chance of success ,its a small study .
Strong Buy on Barchart
http://www.barchart.com/quotes//BNC.TO
3x BUY (current month)
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
Best-Rated Canadian Stocks (Oct 17, 2010)
Below are the best-rated Canadian stocks based on average Wall Street analyst ratings. Each analyst rating is assigned a number ranging from 1 to 5, with 1 being the highest rating (STRONG BUY) and 5 being the lowest rating (STRONG SELL). Then the average is calculated to represent the overall rating of a stock.
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy
re Phase 3 results coming !!Time to get in
I think the major Bladder Cancer final results will be out within 2-3 Weeks .Market Cap of 130 Mil$ 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
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 ...
MARKET CAP OF 130 MILLION $ IS STILL RIDICULOUS FOR THIS BEAUTIFUL COMPANY .
RELAX AND ENJOY THE RIDE TO THE FAIR VALUE LEVEL (7-10$) .STAY LONG AND BE STRONG .
THE NEXT 2-3 WEEKS WILL BE VERY VERY INTERESTING .HAVE A NICE WEEKEND ALL.
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
November 9, 2010
Annual & Special Meeting of Shareholders
* 4:00 p.m. Eastern
* Fairfield Inn & Suites
* 407 North Front Street
* Belleville, Ontario
November 10, 2010
Fiscal 2011
* Q1 Financials
* News Release
UPCOMING MILESTONES 2010 :
UROCIDIN PHASE 3 RESULTS
ECONICHE USDA APPROVAL
BIG MILESTONE PAYMENT FROM ENDO
------------
BIONICHE GETS THE HIGHEST RATING AGAIN = STRONG BUY
http://www.nasd100.com/2010/10/best-rated-canadian-stocks-oct-17-2010.html
Ranking | Company (Ticker) | Average Rating Value | Average Rating
1 AlarmForce Industries (TSE:AF) 1.00 Strong Buy
2 Altius Minerals Corporation (TSE:ALS) 1.00 Strong Buy
3 Amorfix Life Sciences Ltd. (TSE:AMF) 1.00 Strong Buy
4 Aquila Resources Inc. (TSE:AQA) 1.00 Strong Buy
5 Aeroquest International Limited (TSE:AQL) 1.00 Strong Buy
6 Bioniche Life Sciences (TSE:BNC) 1.00 Strong Buy <<<<<<<<<<<<<<<BIONICHE>>>>>>>>>>>>>>
---------------------------------------
ANOTHER STRONG BUY FOR BNC
http://www.barchart.com/quotes//BNC.TO
-----------------------------------------
3 x HIGHEST RATING ON REUTERS TOO = BUY
http://in.reuters.com/finance/stocks/analyst?symbol=BNC.TO
------------------------------------------
rere: Someone bought 55k after Hour at 1,78$ 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.
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 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common Shares 51 - Exercise of options 80,000
.90
After BSDM now CLSN = 10 BAGGER
THE NEXT HYPE WILL START HERE ...
The technology is great and I believe game changing . I think you will be suitably impressed .ALWAYS DO YOUR OWN DD !!!!
Thermodox Phase III results coming .Thermodox has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
Market cap of 37 Mil$ 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."
ARDM volume spike alert over .21
fyi
ADAC also has a spike too
Do you like GNBT?
RALLYYYY WILL CONTINUE TODAY ..PHASE 3 RESULTS COMING IN A FEW DAYS ..DONT MISS IT !!
Two New Presentations within 2 Weeks !!!!
Endo Pharmaceuticals at Jefferies & Co. Global SpecPharma & European Healthcare Conference
Wednesday, October 6, 2010 10:30 a.m. UKT
http://phx.corporate-ir.net/phoenix.zhtml?c=123046&p=irol-EventDetails&EventId=3408691
------
AusBiotech2010
19 to 22 October 2010
http://ausbiotech2010.com.au/uploads/Program/Graeme%20McRae.pdf
-----
STILL VERY VERY VERY CHEAP AT THIS LEVEL .SEE YOU AT 10$+ BY YEAR END !
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
RALLYYY HAS JUST BEGUN ..STILL TIME TO GET IN CHEAP !
BIG PAYDAY IS COMING VERY SOON FOR BNC SHAREHOLDERS .
BNC will blasts above $2+ ,if we break $1,60
http://www.barchart.com/cheatsheet.php?sym=BNC.TO
................................................................................
SINGS OF UROCIDIN PHASE 3 SUCCESS .PLEASE DO YOUR OWN DD !
Urocidin Phase 3 success will trigger a 50-60 million$ milestone payment to Bioniche .Market cap of 100 million$ is wayyyyyyy Undervalued .
1) Chief Medical Officer exercise his options for ~ 130.000 C$
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
.900
...........
2) Urocidin (Bladder Cancer) Phase 3 is a small Studie with 105 Patients,only "20% complete response” required for Phase 3 success .
Previous Positive Phase 2 Results Involving 128 Patients :
We have a 70% complete response rate in patients who failed othertherapies, so our Phase II data, which is in the public domain, shows about 128 patients with an average complete response of about 70%.
..........
3) Complete all DMC ( Data Monitoring Committees) Meetings POSITIV :
Since commencement, nine meetings of the independent DMC have recommended to “continue the trial unmodified”
The DMC is an independent group that acts in an advisory capacity to the Company.Its role is to evaluate the progress of the clinical trial,including monitoring the safety and efficacy data generated in the trial.
..........
4) 21 New Employees since Feb 2010 up from 190 to 211 Personnel :
September 10,
The fully-integrated company employs 211 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety
10/02/10
The fully-integrated company employs approximately 190 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety.
..........
5) Positive Comments by CEO , BladderCancer Forum and Alvaro Morales ( Father of BCG )
CEO Graeme McRae
http://www.quintenews.com/2010/09/banner-year-for-bellevilles-bioniche/
Shareholders will be really happy in two to three years when production of the bladder cancer drug starts to roll onto the market.
BladderCancer Forum (4 months ago)
http://www.bladdercancersupport.org/index.php?option=com_kunena&Itemid=114&func=view&catid=8&id=31827&limit=6&limitstart=12#31862
I can tell you that the people I know at Bioniche are extremely positive about their product.
Alvaro Morales
http://community.advanceweb.com/blogs/al_1/archive/2009/07/13/an-immunotherapy-success-story-bcg-and-bladder-cancer.aspx
Dr Morales, professor of urology and oncologyat Queen’s University, Kingston, Ont., and principal investigator ofthe trial: “My own experience suggests very strongly that the safety profile of MCC is much better than BCG and,certainly, MCC is easier to handle, from the pharmacist’s,nurse’s and physician’s points of view,due to the risk of acquiring a serious infection fromimproper handling of BCG,which is a live bacteria,as opposed to MCC that contains only bacterial cell wall fragments and DNA.”Dr. Morales is editorof The Chronicle of Urology &Sexual Medicine.
........
6) Early (5 months) Exercise of option to take the World Wide Rights for Urocidin by Endo Pharma !
http://www.biospace.com/news_story.aspx?NewsEntityId=170692
Bioniche Life Sciences Inc. (BNC) Achieves Two Additional Milestones Under Licensing Agreement; Endo Pharmaceuticals (ENDP) Takes up Global Rights; Bioniche to Get $8 Million
2/12/2010
-----------------------------------------------------------------------------------------------------------------------------------------------------------
More Information about Bioniche :
http://www.stockhouse.com/Bullboards/MessageDetail.aspx?s=BNC&t=LIST&m=28632016&l=0&pd=0&r=0
Bioniche Life Sciences - Gearing Up For D-Day
9/17/2010 7:01 AM ET
http://uk.quote.com/news/story.action?id=RTT009170701000264
LAST CHANCE TO GET IN CHEAP -- PLEASE do your own RESEARCH !!!
BNC HITS NEW 2 YEAR-HIGH TODAY = MAJOR BREAKOUT COMING
http://www.barchart.com/chart.php?sym=BNC.TO&style=technical&p=DO&d=O&sd=&ed=&size=M&log=0&t=CANDLE&v=1&g=1&evnt=1&late=1&o1=&o2=&o3=&x=28&y=9&sh=100&indicators=SMA%28200%2C16711680%29&chartindicator_2_code=SMA&chartindicator_2_param_0=200&chartindicator_2_param_1=16711680&addindicator=&submitted=1&fpage=&txtDate=#jump
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $4-6 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 50-60 MIL$+ MILESTONE PAYMENT TO BNC
Urocidin (Bladder Cancer) Phase 3 results in September (VERY LOW RISK ) . Only 105 Patients in current Phase 3 .Check out the POSITIVE Phase2 results from 2008 involving 128 Patients (see post below) !!!!
Bioniche Life Sciences (BNC.TO)
Market Cap: 72 Mil$
Cash: 22 Mil $
Price: 0,99 $
***** BUY RATING BY DUNDEE SEC *****
Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 2010; Human Health, with Phase 3 results expected in mid-2010 from lead product, Urocidin, testing for bladder cancer; and FoodSafety, with Canadian approval and a conditional license pending in theU.S. of a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upside potential” for Bioniche investors. His initial diligence suggests that Urocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.
Mitigating the risk somewhat is the 20% “complete response” hurdlerequired for Phase 3. That compares with the company’s Phase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in a population thatwas mainly relapsed but also included a few patients being treated forthe first time.
A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says .
----------------------------------------
TWST: Give us more detail on that pipeline. What is near term and what is a little longer term?
Mr. McRae: The primary technology is called Mycobacterial Cell Wall-DNA Complex, and it sounds like a mouthful but really we found a naturally occurring bacteria where the DNA of the bacteria had a very unusual property ' it can actually kill cancer cells. It kills cancer cells in the face of mutations that would normally stop chemotherapy or radiation therapy from being effective. This DNA is quite unique in that the tumor cells, even when they try to mutate around it, are unable to induce resistance 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 who at the end of the study were disease-free and had really no side effects worth noting due to the product. The patients were able to maintain treatment, whereas without the treatments they drop out because of side effects, so that is our primary technology. It has been shown effective in-vitro in the lab against many different types of cancer. In fact, we can't find a cancer cell it doesn't kill. But in our clinical plan, it is bladder cancer first and prostate cancer second. In prostate cancer, we have completed a Phase I study
IVD
all legit
50 mil authorized
current and unchanged 27.6 mil
recent acquisition of 20 mil by German company
German company part of India company
India company in joint venture with Worldwide Japan based company
good
good
good
and sorry for the delay - this website has serious performance issues being they are UK based and I am in USA
and if anyone is unsure - read SEC filings link on the IHUB IVD company profile and also its very easy to google these companys or just use my links and save yourself a couple hrs of web surfing
I also put some new links/info on the yahoo board today regarding recent report/valuation of the stock
they are so ripe I cant wait to see the PPS by years end!
Can we find this info on their website ?
Chat turns out to be bogus a lot / most of time.
IVD
very nice looking - NASDAQ - under $1 - only 50 mil authorized with a steady untouched 27.6 mil current
low float
FDA play pending by years end
VERY recent new major holders tied to worldwide distribution
here is my DD
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=9869&tid=2274&mid=2274&tof=11&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=9869&tid=2291&mid=2291&tof=2&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=9869&tid=2292&mid=2292&tof=1&frt=2
you are welcome
re BNC ..NEW 52W HIGH woooohooooo.. MAJOR BREAKOUT COMING
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1
re BNC.TO <<< RALLY
POSITIVE RESULTS WILL PUSH THIS STOCK TO $6+ EASILY ..GLTA
Only 105 patients in current PhaseIII !!!!
Positive results from 2008 INVOLVING 130 PATIENTS !!!!
In November 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results
------------------------
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green Light By DMC
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting."
The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial.
re BNC.TO
Buyout is coming !!!!!!!!!!!!!
http://finance.yahoo.com/news/Endo-Pharmaceuticals-Looks-ibd-4281469438.html?x=0&.v=1
Endo Pharmaceuticals Looks For Acquisitions
On Friday August 27, 2010, 4:40 pm EDT
To broaden its product base, Endo has also done some in-licensing. In July, 2009, Endo acquired exclusive rights from Bioniche Life Sciences to develop and market phase-three drug Urocidin for bladder cancer in the U.S. with a global marketing option.
Having bought Penwest, Endo can now make all the decisions about Opana without consultation.[B] It also won't need to pay Penwest the 22% in royalties[/B] that were part of the previous partnership deal.
re BNC.TO RAALLLYYYY
Good News ...BREAKOUT COMING
Bioniche & University of Ottawa Sign Exclusive Global License Agreement for Natural Health Technology - Yahoo! Finance
Bioniche & University of Ottawa Sign Exclusive Global License Agreement for Natural Health Technology
Press Release Source: Bioniche Life Sciences Inc. On Wednesday August 25, 2010, 7:00 am
- potential animal health and human health applications for reduction of anxiety -
re BNC.TO RALLLYYYYYY
THE RALLLLYYYY HAS JUST BEGUN !!!! get in now before its too late .this stock is a lifetime opportunity .
Bioniche life science (BNC.TO) . Market cap of 80 mil$ is a big joke ..
Positive Phase 3 results coming next month .Urocidin for bladder cancer is a real Blockbuster (1-2 Billion Dollars Potential) .
Positive results will trigger a big milestone payment for Bioniche .
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to Endo Pharmaceuticals . Based on incidence of bladder cancer and possible pricing, he figures the global market opportunity for Urocidin in the refractory population could be $800 million. If the second Phase 3 trial expands the Urocidin label to first-line treatment, the market opportunity could grow to an estimated $2 billion.
HUGE BREAKOUT IS COMING ...
http://3.bp.blogspot.com/_4f_p2K3hwOo/THHOw07Y25I/AAAAAAAAKBA/jj2FGUf0ybE/s1600/bnc.png" rel="nofollow" target="_blank" >http://3.bp.blogspot.com/_4f_p2K3hwOo/THHOw07Y25I/AAAAAAAAKBA/jj2FGUf0ybE/s1600/bnc.png
http://www.barchart.com/cheatsheet.php?sym=BNC.TO" rel="nofollow" target="_blank" >http://www.barchart.com/cheatsheet.php?sym=BNC.TO
BNC.TO << RALLLLYYYYYYY
RUNUP STARTED
FDA approval for Econiche (E.coli Vaccine) & Urocidin (Bladder Cancer) Phase III Data in 3Q 2010 !! Bioniche has tremendous upside Potential .Please do your own Homework.
Bioniche Has The Potential To Become The Next 10-Bagger .GLTA !!
Bioniche Life Science (BNC.TO) !!
Market Cap: 74,6 Mio $
Cash: 22 Mio $
Price: 1,03 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 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 a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.
Mitigating the risk somewhat is the 20% “complete response” hurdlerequired for Phase 3. That compares with the company’s Phase 2 results,where patients achieved a 46.4% CR rate at 26 weeks in a population thatwas mainly relapsed but also included a few patients being treated forthe first time.
A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says
Nice, great post alas read it too late, might get in on a dip if this lousy MKT causes it.
FDA APPROVAL NEWS ...
UP 42% in Pre -Market
http://finance.yahoo.com/news/BSD-Medical-Receives-FDA-510k-bw-613610333.html?x=0&.v=1
BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System
Press Release Source: BSD Medical Corporation On Wednesday August 18, 2010, 7:00 am EDT
SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ:BSDM - News) (Company or BSD) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of BSD’s 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market.
re BNC.TO will hit new highs very soon
re Phase III Data in July = Next Dendreon !!!!!!!
Some Positive Signs ..
1. Milestone :
UPDATE 1-Bioniche gets $6 mln milestone payment from Endo Pharma
http://www.reuters.com/article/idUSBNG43432420091106
---
2. Milestone :
Bioniche obtains two additional milestones under licensing agreement with Endo
http://www.tradingmarkets.com/news/stock-alert/bnhlf_endp_bioniche-obtains-two-a
dditional-milestones-under-licensing-agreement-with-endo-777521.html
--
3. Milestone :
All DMC (Data Monitoring Committee are Positive) !!!!
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green Light By DMC
http://www.medicalnewstoday.com/articles/161677.php
---------------------------------------- --
Bioniche Life Science (BNC.TO) !!!
Market Cap: 73 Mio $
Cash: 22 Mio $
Price: 1 $
Buy rating by Dundee Sec (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles: Animal Health, which is expected to generate around $28 million in sales in fiscal 2010; Human Health, with Phase 3 results expected in mid-2010 from lead product, Urocidin, testing for bladder cancer; and Food Safety, with Canadian approval and a conditional license pending in the U.S. of a vaccine for reducing E. coli 0157 in cattle feces, and a pipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upside potential” for Bioniche investors. His initial diligence suggests that Urocidin has a “relatively high overall probability of approval,” even though the first of two planned Phase 3 trials has a moderate level of risk, as the refractory patients enrolled in the trial are a “tougher-to-treat” population than was enrolled in the Phase 2 trial, he says.
Mitigating the risk somewhat is the 20% “complete response” hurdle required for Phase 3. That compares with the company’s Phase 2 results, where patients achieved a 46.4% CR rate at 26 weeks in a population that was mainly relapsed but also included a few patients being treated for the first time.
A second planned Phase 3 trial will test Urocidin head-to-head against the current standard of care, baccilus Calmette-Guerin (BCG) in first-line treatment, “where we expect Urocidin to demonstrate better efficacy, based on prior data, and superior safety and tolerability,” he predicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to Endo Pharmaceuticals. Based on incidence of bladder cancer and possible pricing, he figures the global market opportunity for Urocidin in the refractory population could be $800 million. If the second Phase 3 trial expands the Urocidin label to first-line treatment, the market opportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500 million in annual sales and an estimated $112.5 million in gross profit for Bioniche,” Mr. Martin says .
Phase 3 Data within 2 Weeks !!!
Still a gigantic Opportunity !!
GOOD PHASE III RESULTS IS COMING VERY SOON !!
BNC IS READY TO TAKEOFF
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=
Only 105 patients in current PIII !!!!
In November 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results
Phase III Data in July = Next Dendreon !!!!!!!
Urocidin (Bladder Cancer) Phase III Results within 4 Weeks .Lots will want this goldmine in the future. Please do your own Homework .
Bioniche Life Science (BNC.TO) or (BNHLF.PK) Canadian Stock !!!
Market Cap: 75 Mio $
Cash: 22 Mio $
Price: 1,03 $
Buy rating by Dundee Sec (June 2010)....
Bioniche has three businesses with diversified risk/reward profiles: Animal Health, which is expected to generate around $28 million in sales in fiscal 2010; Human Health, with Phase 3 results expected in mid-2010 from lead product, Urocidin, testing for bladder cancer; and Food Safety, with Canadian approval and a conditional license pending in the U.S. of a vaccine for reducing E. coli 0157 in cattle *****, and a pipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upside potential” for Bioniche investors. His initial diligence suggests that Urocidin has a “relatively high overall probability of approval,” even though the first of two planned Phase 3 trials has a moderate level of risk, as the refractory patients enrolled in the trial are a “tougher-to-treat” population than was enrolled in the Phase 2 trial, he says.
Mitigating the risk somewhat is the 20% “complete response” hurdle required for Phase 3. That compares with the company’s Phase 2 results, where patients achieved a 46.4% CR rate at 26 weeks in a population that was mainly relapsed but also included a few patients being treated for the first time.
A second planned Phase 3 trial will test Urocidin head-to-head against the current standard of care, baccilus Calmette-Guerin (BCG) in first-line treatment, “where we expect Urocidin to demonstrate better efficacy, based on prior data, and superior safety and tolerability,” he predicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to Endo Pharmaceuticals (ENDP 22.13 ?1.10%) (NASDAQ:ENDP). Based on incidence of bladder cancer and possible pricing, he figures the global market opportunity for Urocidin in the refractory population could be $800 million. If the second Phase 3 trial expands the Urocidin label to first-line treatment, the market opportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500 million in annual sales and an estimated $112.5 million in gross profit for Bioniche,” Mr. Martin says.
BIG NEWS coming in june !!!
Markman hearing in june// If Positive = BIG BOOST FOR IGXT
300 Million US$ Market Potential for CPI-300 (antidepressant) approval in 4Q 2010 or early 1Q 2011 !!
Intelgenx (igxt.ob)
Market Cap 15 Mio$
Price : 0,45 $
In addition, we have a meeting scheduled with FDA in early June to address their complete response letter and clarify the required steps to obtain product approval. Finally, the Markman hearing in respect of the Biovail litigation is also scheduled for early June, and we remain optimistic for a positive outcome. The timing of this acquisition should yield substantial value to the company and its shareholders because we believe it is an excellent product that will become commercialized in the near future."
Objectives for the next 12 Months
?
Q2, 2010 Complete pilot study for ED film
?
Q2, 2010 Meet with FDA for CRL response (JUNE)
.
Q2, 2010 Markman hearing (Biovail litigation) (JUNE)
?
Q3, 2010 Complete pivotal migraine study
?
Q3/Q4, 2010 Respond to FDA CRL letter
?
Q4,2010 File ANDA antihypertensive product
?
Q1, 2011 Approval of CPI-300 NDA
Mr. Biospecialist,
Could you please compare the pps potentials of bsdm vs clsn vs dcth?
They all look good to me; am very interested in your take on this due to your obvious familiarity in detail with all 3 of these situations.
Have you also checked out mnkd or posc? They also look interesting, but perhaps longer term, imho.
Very many thanks for your reply.
D6
BSDM..FDA Approval in JUNE !!!!!!!!!!!!!!
This stock has tremendous upside potential ..Please do your own DD !!!
2 Approvals (BSD-2000 and MTX-180) within 2 Months !!!
BSD MEDICAL (BSDM)
Market Cap : 31 Million$
Cash : 8 Million$
Price : 1,32 $
BSDM filed a 510K for the MTX-180 with the FDA on March 22. Review period is usually 90 days OR LESS. That puts approval on or before June 22, 2010. About 3-4 weeks from today at the latest.
About the MTX-180
The MTX-180 will work well, and will the be-all, end-all of the ablation market. Every doctor doing ablations will end up with one.
Remember BSDM has done it before, with the device they built for treating BPH. The TherMatrx100.
That device dominated the market, put Urologix (competitor) out of business, and became the system of choice when treating BPH. I believe BSDM sold the rights to it to American Medical Devices Inc. for about 40 million dollars, and that is how they have funded themselves, and the development of the MTX-180 over the last 5 years.
The MTX-180 should be, by all accounts, a cash cow that puts BSDM back on the map, and will draw much attention to their other more expensive hyperhtermia products.
MTX-180 is cheap (maybe 25,000 $$$ ?) but the replaceable parts for surgeries are $900-$3,200 PER SURGERY, and those parts will be sold by BSDM at a 50-60 percent margin. A "razor blade" business if you will.
You do the math.
If BSDM gets just one hundred MTX-180's out there, just 2 for every state in America, and each one does 5 ablations a day, 30 per week, that's 1,560 per year for each one. Multiply by 100 systems, that's, 156,000 ablations per year in the U.S. alone.
At $900-$3,200 x 156,000 you get 140 million to 561 million dollars in revenues generated in 1 year from 100 machines. That's some serious revenues! For a company with just 22 million shares outstanding!
Getting the picture now? What if they end up selling 500 MTX-180's???
Over 600 of the TherMatrx100 BPH treatment systems were sold in the last 6 years. BSDM can do it agian, and the MTX-180 is expected to dominate the marketplace and sell MORE.
MTX-180 could be all this company needs to get the stock into the double digits. Any sales from BSD-2000 is just gravy on top of the meat, the MTX-180.
June will be here in 2 weeks.
All those revenues will now be spread out over just 23 million shares, 11 million of them closely held.
No debt, cash rich now (7.5 million $$) and a new product launch in June. That is the reality. And don't forget, China is buying BSD-2000's, there is an ongoing clinical trial for Thermodox combined with the BSD-500, and the HDE submission for the BSD-2000 can be approved any day now.
This stock can triple in ONE day.
RAALLLYYYYYYYYYYYYYYYYYYYYYYYYYYYYy
http://de.advfn.com/p.php?pid=staticchart&s=TSE%3ABNC&p=0&t=37&vol=1
TOP PICK 2010 ..PLEAS READ
***** DONT MISS THE BIG OPPORTUNITY ***** ALWAYS DO YOUR OWN DD !!!!
Urocidin (Bladder cancer) PIII results in 2Q 2010 .Urocidin has BLOCKBUSTER POTENTIAL !!!!
Bioniche Life Science (BNC.TO) or (BNHLF.PK) Canadian Stock !
Market Cap: 97 Mio C$
Cash: 30 Mio C$
Price: 1,12 C$
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
Bioniche to Get up to $130M in Urology Deal with Endo
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc
Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70
Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php
Discussion board of people dealing with bladder cancer and discussing BCG treatment and MCC
http://www.inspire.com/groups/bladder-cancer-advocacy-network/discussion/bcg-protocol/?page=1#replies
Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
PMBS will go over 5$ very very soon .Better get in before its too late ..
Huge Pipeline ..
LipiGesic™ M
LipiGesic™ M provides acute relief from migraine headaches, and contains the herbs feverfew and ginger as principal ingredients. PuraMed believes that its specific formulation of these herbs for its migraine remedy is unique and proprietary, providing relief from these severe headaches in minutes. The Company believes it will capture a material segment of the huge migraine headache remedy market. We believe that Americans spend in excess of $6 billion annually on headache pain relievers, and that over half of sufferers of migraine headaches rely exclusively on non-prescription medications.
We believe that at least 30 million Americans suffer from chronic migraine headaches with over 20 million of them having “severe” migraine conditions. Thus migraine headaches constitute a severe and disabling condition for millions of people. We further believe that the economic burden alone to the U.S. economy is in excess of $20 billion annually.
LipiGesic™ M is effective, available as a non-prescription remedy, without any known side effects, and affordable compared to more expensive migraine drugs based on prescription chemical formulations.
LipiGesic™ PM
LipiGesic™ PM is a new class of non-prescription sleep aid without any known side effects, and contains a proprietary blend of natural ingredients including Valerian, St. John’s Wort, and Chamomile. We believe that the proprietary blend of these ingredients provides an effective remedy for insomnia and other sleep disorders. The sleep aid market features products based primarily on chemical antihistamines.
Accordingly, the LipiGesic™ PM product provides a wide open market opportunity for an effective, natural alternative to prescription medications, which are somewhat addictive and often cause withdrawal symptoms and other side effects. We have priced LipiGesic™ PM as a premium sleep aid product, which provides us with a projected gross margin of approximately 80%. This large margin should leave us substantial room for ample introductory promotion, product allowances and other incentives conducive to achieving rapid market penetration.
Similar to the migraine remedy market, the market for sleep aid products represents a very large segment of the overall healthcare products marketplace. We believe that over half of all adults in the U.S. suffer from sleep disorders, and that many of them experience persistent insomnia. The National Center on Sleep Disorders has reported that there are as many as 70 million problem sleepers in the U.S. with many of them suffering from chronic sleep disorders. We believe that insomnia is second only to pain as a healthcare complaint.
Future LipiGesic™ Products
We have completed development of additional non-prescription products, which we intend to launch commercially over the next couple years after establishing a solid market for our initial two products. These other PuraMed products include:
LipiGesic™ H – provides relief for common tension headaches which afflict a majority of American adults from time to time. This remedy provides headache relief features a unique proprietary formulation of St. John’s Wort and common aspirin.
LipiGesic™ Smoker’s Pal – provides relief from the symptoms associated with nicotine withdrawal with the added benefit of an appetite suppressant.
LipiGesic™ RLS – provides relief of problematic leg cramps associated with Restless Leg Syndrome affecting a large segment of the population in the U.S.
LipiGesic™ GI – provides relief of symptoms associated with nighttime reflux disorders.
LipiGesic™ CS – provides fast relief for canker sore outbreaks.
RALLY ..GET IN NOW !!!
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 5$ WITHIN 2 WEEKS !!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 2$ WITHIN 2 WEEKS !!!
GET IN NOW BEFORE THE STOCK GETS DISCOVERED . THIS IS A 10 BAGGER EASILY !!!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
PIII Results within 6 Weeks !!!
Urocidin (Bladder cancer) PIII results in April 2010 .Urocidin has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
PIII RESULTS WILL BE POSITIVE ..MARK THIS POST !!!
Bioniche Life Science (BNC.TO) or (BNHLF.PK)
Market Cap: 86 Mio $
Cash: 30 Mio $
Price: 0,96 $
Bioniche Life Sciences Inc. (“Bioniche”; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating UrocidinTM in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy – Bacillus Calmette-Guérin (BCG).
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche “continue the trial unmodified until the next scheduled or triggered meeting.” The next scheduled meeting of the Committee is scheduled to occur in October.
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
AEMD or TMEN
keep eye on AEMD here
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