DD for BionicheRepost of DD from earlier post by Dolllarchamp from Novembr 4th:
THE RECENT PHASE 3 STUDY IS MUCH SMALLER COMPARED TO THE PREVIOUS BIG SUCCESS PHASE 2 STUDY.
THE CURRENT MARKET CAP OF 133 MILLION$ IS RIDICULOUS FOR A BIG BLOCKBUSTER CANDIDATE LIKE UROCIDIN .
Urocidin (Bladder Cancer) Phase 3 is a small Studie with 105 Patients,only "20% complete response” required for Phase 3 success .
UROCIDINREACHES70% COMPLETE RESPONSE IN 128 PATIENTS .THATS DEFINITELY ABIGBLOCKBUSTER,DENDREON ONLY REACHES 23% CR WITH PROVENGE AND NOW THEYHAVE A MARKETCAP OF 5 BILLION$ .
BLOCKBUSTER PHASE II RESULTS :
ThisDNAis quite unique in that the tumor cells, even when they try tomutatearound it, are unable to induce resistance tothis compound;andit'sextremely safe. We have a 70% complete response rateinpatients whofailed other therapies,so ourPhase II data, which isin the publicdomain, showsabout 128patients with an average complete response of about 70%.Thesearepatients who at the end of the study were disease-free and hadreallynoside effects worth noting due to the product. Thepatientswere able to maintain treatment, where as without the treatmentstheydropout because of side effects, so that isour primary technology.It hasbeen shown effective in-vitro in the lab against many differenttypesofcancer. In fact, we can't find a cancer cell it doesn't kill.
ENDOKNOWSTHEY HAVE A MEGA BLOCKBUSTER IN THEIR HANDS ,THATS WHY THEYKEEPITSECRET .I THINK BIONICHE IS ENDO`S NEXT BUYOUT CANDIDATE .
LOOK AT BIONICHE´S SHARE PRICE THE STOCK IS UP 400% IN ONE YEAR AND CONTINUES TO CLIMB HIGHER . WHAT DOES THAT TELLS YOU ???
DO YOU REMEMBER :
Dendreon went from 1.60 to 54.06 with 143 million shares outstanding. No splits, no dilutive offerings in that time period.
BIONICHE HAS 79 MILLION SHARES OUT AND NO SPLITS ,NO DILUTION ,NO INSIDER SELLING EVEN AFTER 400% PRICE INCREASE .
CONCLUSION :
WE SIT ON A GOLDMINE ..YOU WILL SEE THAT VERY SOON .
Upcoming Milestones 2010 :
Urocidin (bladder cancer vaccine) Phase 3 results
Major Milestone payment from Endo for Phase 3 success
Econiche (e.coli vaccine) approval in USA
FROM ENDO´S CC 1 NOV 2010
https://www.morningstar.com/earnings/PrintTranscript.aspx?id=18732547
As a finalnote, we plan to begin enrolling patients in the next study of Urocidinin refractory bladder cancer during the fourth quarter.This will serve asa registration trial comparing Urocidin to Mitomycin,thecurrentstandard treatment for this condition. Urocidin is a novel treatment forbladder cancer and reflects our commitment to this therapeutic area.
I am pleased with ourclinical progress and look forward to resolving our marketingapplications that are pending before the FDA.
Ivan Gergel, M.D. - EVP, Research & Development:
Theother one,the Urocidinstudy, the phase III study that was justcompleted. We arefinalizingsome of the data review, but we hopefullywill be able torelease datefor that quite shortly – from that studyquite shortly.
Gearing up for d-day ..Article
https://www.rttnews.com/Content/TopStories.aspx?Id=1421944
Bioniche to Get up to $130M in Urology Deal with Endo
https://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Urocidin Potential New Treatment for Bladder Cancer
https://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70
Crystal Research 18.02.2010
https://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
POSITIVE SIGNS OF BIG PHASE 3 SUCCESS
1) Chief Medical Officer exercise his options for ~ 130.000 C$
Sep 20/10 Sep 20/10 Charette, Francois Guy Direct Ownership Common 51 - Exercise of options 50,000 $1.100
Sep 20/10 Sep 16/10 Charette, Francois Guy Direct Ownership Common 51 - Exercise of options 80,000
.900
...........
2) Urocidin (Bladder ) 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 failedothertherapies, so our Phase II data, which is in the public domain,showsabout 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 DMCis an independent group that acts in an advisory capacity to theCompany.Its role is to evaluate the progress of the clinicaltrial,includingmonitoring the safety and efficacy data generated inthetrial.
..........
4) 21 New Employees since Feb 2010 up from 190 to 211 Personnel :
September 10,
The fully-integrated company employs 211 skilled personnel and hasthree operating divisions: Human Health, Animal Health, and Food Safety
10/02/10
The fully-integrated company employs approximately 190 skilledpersonnel and has three operating divisions: Human Health, AnimalHealth, and Food Safety.
..........
5) Positive Comments by CEO , BladderCancer Forum and Alvaro Morales ( Father of BCG )
CEO Graeme McRae
https://www.quintenews.com/2010/09/banner-year-for-bellevilles-bioniche/
Shareholders will be really happy in two to three years whenproductionof the bladder cancer drug starts to roll onto the market.
BladderCancer Forum (4 months ago)
https://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
https://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 ownexperience suggests very stronglythat the safety profile of MCC is muchbetter than BCG and,certainly, MCC iseasier to handle, from thepharmacist’s,nurse’s and physician’s points ofview,due to the risk ofacquiring a serious infection fromimproper handling o fBCG,which is alive bacteria,as opposed to MCC thatcontains only bacterial cell wallfragments and DNA.”Dr. Morales is editorof The Chronicle of Urology&Sexual Medicine.
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6) Early (5 months) Exercise of option to take the World Wide Rights for Urocidin by Endo Pharma !
https://www.biospace.com/news_story.aspx?NewsEntityId=170692
Bioniche Life Sciences Inc. (BNC) Achieves Two Additional MilestonesUnder Licensing Agreement; Endo Pharmaceuticals (ENDP) Takes up GlobalRights; Bioniche to Get $8 Million
2/12/2010