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After establishing the analytical performance of the assay in an outsourced GLP laboratory, Amarantus plans to conduct a small clinical performance study at an independent laboratory in the second quarter of 2013 to verify the previously published findings
The published findings were verified hence BD agreeing to be the Development Lab. Now they will work together to Validate the accuracy of the Test leading to CLIA launch.
AMBS. Verified. Now soon in process of Validation.
GL LymPro
Thanks Again. ITZA. Great call on ONCI. And its still going!!!!!!!!
Full control of LymPro can also be 51% or more. In an Agreement.
And by the wording of the IP rights it seems to imply there will be new applications/indications for the LymPro Test
We shall see.
GL2ALL
Excellent Call by Itza-Sherbet on VOIS
Thanks for another 100% plus Gain
VOIS = $$$$$$
Keep up the great calls..
Results obtained in phase 1 trials needed to be verified. AMBS hired BD to verify these results.
And now BD has Agreed to be the Development Lab partner.
Speculate
BD was hired to do a validation study first for AMBS.
Now they have agreed to develop the test.
Speculator opinion
Becton Dickinson ("BD") has agreed to become the development laboratory for LymPro Test
Yeah your right, BD likes to waste their time.
No we did not know that the test was validated. But it is now.
Becton Dickinson ("BD") has agreed to become the AMBS development laboratory for LymPro Test
Read it again.
who carries a basket of eggs in the Ocean?
you should move the decimal point to the left to be more accurate
GL2U
ONCI $$$$$
Seems like Exonhit AclarusDX's accuracy is very low
http://www.ncbi.nlm.nih.gov/pubmed/22785402
I am no scientist but did i read this wrong?
LymPro has shown a much higher accuracy %
I guess I will continue to read on.
AMBS - LymPro
Correct me if I am wrong but Gerald and Dr. Simon ( World Renowned AD Biomarker Expert)have gone on record saying LymPro is the furthest along Blood Test for AD and is on pace to be 1st to market.
I will look into the other companies but..
AMBS
Nice find on AMBS
Can you put the Board's name in "Quotes" Atleast "CyberCentrifuge" like this our Board appears at the Top of the list for people who follow us
no worries... Was in Panama for a week --went to inspect Old Cuban Missiles and Relic weapons.... told them they are giant Paper weights - US Government said I can come back
shhhhh don't tell anyone
Mod Assist ---- where is Delete and Ban buttons? thats all i need to know
boat loads of ONCI for me.. come Monday
GL2ALL
Holy Crap.. finally found the Address here.. damn GPS was not working..
:)
Already old news but TDA Chill also gone. Added today thru them
TDA chill still in place for AMBS.
Supreme Court does not mess when that much money and science is involved. They always will find a compromise. AMBS patents were never in jeopardy.
Also AMBS will file PreSubmission App to FDA for LymPro in 3rd Quarter 2013 was also noted in the original Chart they removed from the LymPro White Paper
they are just going through the formalities..its all working to plan. this will get green lighted and put in the express lane IMO... remember our government is focused on helping advance AD treatments and Early diagnostics is ultra important to that.
GL2ALL
"TBIs and their effects on amateur and professional football players are emerging as a rallying point to better understand the brain and treatments," said former college football and hockey player Gerald E. Commissiong, also president and CEO of Amarantus BioScience Holdings, Inc. (OTCQB: AMBS) -- one leg of #C4CT. "We are proud to be among the first to unite the groups affected."
Amarantus (www.Amarantus.com) is showing promising early results. Its primary therapeutic program, called Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF), shows the ability to treat concussions.
In addition to Amarantus, the other legs of the #C4CT alliance are just as vital -- advisory firm Brewer Sports International (BSI), Toi Cook Management Group (TCMG) and Banyan Biomarkers. Banyan Biomarkers has an ongoing 2,000-subject clinical study that is funded by a $26.3 million contract from the Department of Defense.
"As an ex-NFL player, I experienced hundreds of violent collisions, and have teammates and friends who suffer the lasting effects of TBI," says Jack Brewer, CEO at BSI. "Now it's up to all NFL players to use our influence to catalyze research in TBI."
http://www.statejournal.com/story/22132740/making-headway-against-traumatic-brain-injuries
AMBS - Perhaps most interesting from a time-to-market standpoint, is the emerging evidence that MANF has activity in certain rare and ultra-rare orphan diseases. The orphan drug strategy that management is pursuing will seek a path to commercialize MANF as expeditiously and cost-effectively as possible, and potentially faster than Parkinson's, Traumatic Brain Injury or Myocardial Infarction. We are evaluating the possibilities of the MANF program in various orphan disease areas through our recent grant from the Center of Excellence for Apoptosis Research and collaborations with academic labs. We expect this process to be completed within a calendar year, and we will be updating shareholders on an on-going basis regarding results of experiments as data becomes available. The key advantage to this strategy is that the Investigational New Drug (IND) protocols required for our Parkinson's program will overlap with our orphan drug program; therefore, an additional IND should be attainable in the same timeframe.
http://ir.stockpr.com/amarantus/company-news/detail/353/amarantus-biosciences-issues-ceo-letter-to-shareholders
Also AMBS delivery method for MANF also depends on the Indication it will target, if its in the Eye or Ear it will be easier to deliver there than into the brain IMO .. I am no expert either correct me if I'm wrong, but I also remember in the past AMBS was involved with a company that delivered therapeutics via a patented inhaling device..
Thanks clearing up what everyone already knows. AMBS's Orphan strategy has not been announced but it will be. You will know soon enough what Orphan Diseases they will be going after with fast track and quicker to market avenues.
So you want the news before its announced? You need to wait, the studies are on going. AMBS will announce them*(plural) when the time comes.
once the Orphan IND's targets are announced. MANF is the lead therapeutic with greater potential. This is ramping up all at the same time. AMBS
Let not forget the thing that Dr. Rubinfeld Co-Founder of AMGEN was most excited about when it came to AMBS & MANF was: ORPHAN INDICATIONS
I feel we will have some interesting times ahead before we get to 2014 due to the IND's they are looking into..
IND Applications for Orphan indications have a really high approval rate..... and they are talking about multiple indications that MANF has begun to show good data in for Orphan Diseases..
IND Approvals = CASH from the Heavens
GL2ALL
$AMBS$
didn't you say you didn't do to well here on AMBS? why would anyone listen to your advice now? I think you need to check your entry strategy IMO..
For the AMBS speculators, it is kind of obvious in my opinion the bridge loan was arrange to pay for the validation study for LymPro and there already is a financing deal in place with BD contingent on positive results. Who wants to be in? Who is out
PS. I called the Becton Dickinson connection. And the intriguing part to me is the division involved - BD Biosciences. Not BD Diagnostics. Which in my opinion means they are rather interested in more than an AD test. But thats just me and how my mind works.
GL2ALL
AMBS LymPro = Alzheimer's 1st ever diagnostic blood test and should be 1st to market and they have one of the top experts in AD Biomarkers on the board of advisors to walk thus through to fruition.
AMBS in 8 Billion Dollar market. Not including diagnostics. Another Billion there.
The upcoming activities related to Amarantus’ Parkinson’s disease program include:
Create mammalian GMP production processes for MANF; the Company has sourced the expertise for these activities, and has started development of the supporting analytical and bioanalytical assays;
Form a partnership agreement in the third quarter of 2013 with a firm specializing in Convection-enhanced delivery (CED) of drugs to the brain;
Initiate non-human primate pharmacology studies in Parkinson's disease models in the second half of 2013 in order to establish an appropriate dosing regimen for human clinical studies;
Potentially evaluate MANF gene therapy based upon upcoming developments in the field of neurotrophic factors for Parkinson’s disease, and the Company’s current patent position whereby the Company owns exclusive rights to MANF gene therapy applications in all vector systems.
Additional planned activities are expected to include:
Conduct pharmacokinetic and pharmacodynamic (PK/PD) studies, with data available in the third quarter of 2013, to evaluate the biological properties of MANF when administered systemically, with data to be released as it becomes available;
Conduct pharmacology studies in traumatic brain injury, ischemic heart disease, diabetes and certain other animal models in the third quarter of 2013, with data to be released as it becomes available;
Evaluate MANF in a variety of animal models of orphan diseases in the third quarter of 2013 that represent significant market opportunities, and where there is limited or very limited competition;
Initiate MANF toxicology studies upon development of a master cell bank of MANF protein material as one of the final pre-IND steps;
File an IND in 2014.
“Based on our progress with these preclinical activities and the interest and level of data in specific indications, we will seek to partner with biopharmaceutical companies or appropriate not-for-profit disease foundations in order to accelerate our development program and assist in recruiting patients for future clinical studies,” said Mr. Commissiong. “We will prioritize our clinical development programs based upon the outcome of the pharmacology studies that will begin in the third quarter of 2013 for the indications outlined here today. We intend to give highest priority to those indications where we have a shorter path to market, and where non-dilutive financing is available to support further development. Fortunately for the Company, it is likely that many of the pre-clinical studies will have applications across indications, meaning we will get the advantage of a particular set of data enabling multiple indications.”
The Company will seek to gain ‘Breakthrough,’ ‘Fast Track’ and/or ‘Orphan Drug Designation’ status with the FDA where the Company believes the data generated justifies such a designation, potentially significantly reducing the time to market for MANF and/or improving the potential economic outcome for the Company.
The Company believes MANF could address the following very significant market opportunities:
Parkinson’s disease: $1 billion
Traumatic Brain Injury: $200 million
Ischemic Heart Disease: $2 billion
Diabetes: $2 billion
Orphan diseases: $2 billion
http://ir.stockpr.com/amarantus/company-news/detail/674/amarantus-announces-preclinical-development-timeline-for-manf-therapeutic
“The LymPro Test is potentially the first available blood test for Alzheimer’s disease,” said Gerald E. Commissiong, President & CEO of Amarantus. “With this agreement, we expect to have initial data available in the third quarter of 2013, and now have the capabilities required to place LymPro on a path for commercialization in 2014.”
data in this 3rd quarter. This is what bring in the $$$$$$$$$ to develop LymPro.
And yet i have profited 500% on BMSN each time you post info like this. Thank you for your DD on BMSN
Beauty is in the eye of the beholder. BMSN ran to .017 on IND application. IND approval? .03 -.05 is really conservative.
GL2ALL
Actually the approval rate of Orphan indication IND's is rather high. In the 80+ percentile. Look it up , no lie. BMSN's IND will be given green light soon.
Have a nice day
Thanks for the in depth analysis of AMBS , LymPro and MANF. It is greatly appreciated.
Smh
Why is EPGL O/S on ihub saying its 700 Million shares? Anyone know?