Yup, this is long. But it has also been a full year. And no where do I see inconstancies. I don't understand why you are gung-ho on "blaming" ? GC and really for what? The share price drop? Or not following through on what may have been interpreted by some Message Board Shareholders.
The LymPro commercial development strategy is becoming clearer as we finalize the business plan for our Diagnostics division and interact with the key stakeholders involved in LymPro’s development. In late December our team reviewed the Company’s development, regulatory, reimbursement and marketing plans with experts in the field, and we are now preparing to implement the strategy for LymPro’s most lucrative path forward for Amarantus shareholders. It has also become clear while interacting with the Alzheimer’s community that there is a tremendous amount of interest in LymPro’s potential to become the first blood-based test for Alzheimer’s disease. Cell-cycle dysfunction is becoming a central component to Alzheimer’s research as it relates to amyloid and tau pathology, making LymPro directly relevant to mainstream biology. The next major milestones for LymPro are the completion of the Analytical Performance Package and the first Clinical Performance data. A significant opportunity exists for LymPro development in national and international jurisdictions following these key sets of data. We remain on track to commercialize LymPro in the second half of 2014 .
- See more at: http://www.thechairmansblog.com/amarantus-bio...W5ovf.dpuf
The Company expects to commercialize LymPro in the second half of 2014 under CLIA in Alzheimer’s disease , one of the largest and most underserved markets in the world ($200B+ in the US alone, $500B+ worldwide) where we will seek to fulfill the key unmet medical need of early diagnosis. While CLIA will not allow the Company to generate the revenues that a full FDA approval eventually will, we believe there is an opportunity to generate meaningful revenues that will offset development costs in other areas until such a point where we are able to realize revenue generation in other categories; - See more at: http://www.thechairmansblog.com/amarantus-bio...3c4dB.dpuf
. Since the fourth quarter, when we last updated our shareholders on the progress of LymPro, we have achieved a number of key milestones that we believe will add significant value to our product as well as mitigate risk in certain critical areas in order to increase the net present value of our assay. As a result of these steps, we are in a position to initiate a partnering process for the CLIA commercial launch of LymPro in the second half of 2014. The Company has made progress in the following areas : - See more at: http://www.thechairmansblog.com/amarantus-bio...P6k0a.dpuf
In summary, we have continued to make progress in recent months with our LymPro product development program and have put ourselves in a position to develop a meaningful commercialization and marketing partnership for our CLIA assay as we head into the second quarter of 2014. - See more at: http://www.thechairmansblog.com/amarantus-bio...P6k0a.dpuf
With regards to a partnership agreement to allow for the CLIA launch of LymPro in 2014, we are currently working through the intricacies of what such an agreement would entail. We have identified the laboratory that we believe has the technical know-how and marketing capabilities required for the launch of the LymPro Test both within the clinical trials setting to support pharmaceutical development , as well as a commercial launch under CLIA. - See more at: http://www.thechairmansblog.com/amarantus-bio...9ZkqA.dpuf
We are well positioned to transfer LymPro to a commercial lab where our protocols will be implemented according to commercial standards under CLIA. We believe the data sets presented next week will provide the basis for initial LymPro sales to pharmaceutical companies and Key Opinion Leaders who are continually seeking to improve their diagnostic paradigms . - See more at: http://www.thechairmansblog.com/amarantus-bio...Z5OB3.dpuf
Some may ask, “How will you get another clinical study completed by the end of the year in the CLIA lab, as is required to support submission?” The answer is that we are proving right now that we can execute under such timelines with the current study. This is where the relationships and expertise and experiences of Dr. Kirby’s over 400 clinical trials are a huge advantage for Amarantus. We are establishing a well-oiled clinical organization capable of translating protocols to practice, and ultimately to data at a very rapid pace .
We remain on track to complete the partnering process with our CLIA lab by the end of the summer, transfer the analytical process from BD to the target partner (a process that these organizations have completed extremely successfully several times), and achieve CLIA submission within our targeted timeframes. We believe the raw data for LymPro overwhelming demonstrates its validity even in suboptimal conditions, and now we are poised to move it to the main stage. We believe that by the time AAIC comes around in 2015, the data that we will be presenting will be the subject of significant oral presentations. We are excited with the progress made at AAIC this year and the credibility we have injected back into LymPro after rescuing it from PLS, and believe that we are very well positioned for the second half of 2014. LymPro has a bright future and we are happy to have brought it back to life for the benefit of patients and shareholders.
- See more at: http://www.thechairmansblog.com/amarantus-bio...OJvKJ.dpuf
We project a partnership agreement for LymPro will follow shortly after the completion of the LP-002 study, and the Company is weighing strategic options which include a potential ‘spin-out’ of our diagnostics division (which includes LymPro and NuroPro); - See more at: http://www.thechairmansblog.com/amarantus-bio...yyooo.dpuf
This arrangement is not a classic partnership, as Amarantus is maintaining all intellectual property rights to current and future versions of LymPro at the current time. This is a services agreement that gets the ball rolling on the CLIA process as we make progress on our ongoing LP-002 clinical study and puts Icon in a sub-contractor relationship with respect to LymPro. Icon will be providing central laboratory services to Amarantus in a fee-for-service arrangement, which is their primary business model. This services agreement extends over four years and covers LymPro’s central laboratory requirements under CLIA (under CLIA, only 1 laboratory facility can run a Laboratory Developed Test), in addition to consulting support for Eltoprazine’s further clinical development and our MANF program as we move it towards human trials. With this agreement, we also gain access to a global distribution network for LymPro, including central laboratories in Europe, Singapore, India and China that will allow LymPro to enter these new markets seamlessly through an already established distribution framework .
We are continuing to evaluate shareholder value creating arrangements for our diagnostics division, including a potential ‘spin-out’ or other business arrangements that would make strategic sense for the various LymPro and Amarantus stakeholders. We will not be giving additional details related to those possible arrangements in today’s business update call, as we are contractually prohibited from doing so.
- See more at: http://www.thechairmansblog.com/amarantus-bio...csw5L.dpuf
The LymPro commercial development strategy is becoming clearer as we finalize the business plan for our Diagnostics division and interact with the key stakeholders involved in LymPro’s development. In late December our team reviewed the Company’s development, regulatory, reimbursement and marketing plans with experts in the field, and we are now preparing to implement the strategy for LymPro’s most lucrative path forward for Amarantus shareholders. It has also become clear while interacting with the Alzheimer’s community that there is a tremendous amount of interest in LymPro’s potential to become the first blood-based test for Alzheimer’s disease. Cell-cycle dysfunction is becoming a central component to Alzheimer’s research as it relates to amyloid and tau pathology, making LymPro directly relevant to mainstream biology. The next major milestones for LymPro are the completion of the Analytical Performance Package and the first Clinical Performance data. A significant opportunity exists for LymPro development in national and international jurisdictions following these key sets of data. We remain on track to commercialize LymPro in the second half of 2014 .
- See more at: http://www.thechairmansblog.com/amarantus-bio...W5ovf.dpuf
The Company expects to commercialize LymPro in the second half of 2014 under CLIA in Alzheimer’s disease , one of the largest and most underserved markets in the world ($200B+ in the US alone, $500B+ worldwide) where we will seek to fulfill the key unmet medical need of early diagnosis. While CLIA will not allow the Company to generate the revenues that a full FDA approval eventually will, we believe there is an opportunity to generate meaningful revenues that will offset development costs in other areas until such a point where we are able to realize revenue generation in other categories; - See more at: http://www.thechairmansblog.com/amarantus-bio...3c4dB.dpuf
In summary, we have continued to make progress in recent months with our LymPro product development program and have put ourselves in a position to develop a meaningful commercialization and marketing partnership for our CLIA assay as we head into the second quarter of 2014. - See more at: http://www.thechairmansblog.com/amarantus-bio...P6k0a.dpuf
With regards to a partnership agreement to allow for the CLIA launch of LymPro in 2014, we are currently working through the intricacies of what such an agreement would entail. We have identified the laboratory that we believe has the technical know-how and marketing capabilities required for the launch of the LymPro Test both within the clinical trials setting to support pharmaceutical development , as well as a commercial launch under CLIA. - See more at: http://www.thechairmansblog.com/amarantus-bio...9ZkqA.dpuf
We are well positioned to transfer LymPro to a commercial lab where our protocols will be implemented according to commercial standards under CLIA. We believe the data sets presented next week will provide the basis for initial LymPro sales to pharmaceutical companies and Key Opinion Leaders who are continually seeking to improve their diagnostic paradigms . - See more at: http://www.thechairmansblog.com/amarantus-bio...Z5OB3.dpuf
Some may ask, “How will you get another clinical study completed by the end of the year in the CLIA lab, as is required to support submission?” The answer is that we are proving right now that we can execute under such timelines with the current study. This is where the relationships and expertise and experiences of Dr. Kirby’s over 400 clinical trials are a huge advantage for Amarantus. We are establishing a well-oiled clinical organization capable of translating protocols to practice, and ultimately to data at a very rapid pace .
We remain on track to complete the partnering process with our CLIA lab by the end of the summer, transfer the analytical process from BD to the target partner (a process that these organizations have completed extremely successfully several times), and achieve CLIA submission within our targeted timeframes. We believe the raw data for LymPro overwhelming demonstrates its validity even in suboptimal conditions, and now we are poised to move it to the main stage. We believe that by the time AAIC comes around in 2015, the data that we will be presenting will be the subject of significant oral presentations. We are excited with the progress made at AAIC this year and the credibility we have injected back into LymPro after rescuing it from PLS, and believe that we are very well positioned for the second half of 2014. LymPro has a bright future and we are happy to have brought it back to life for the benefit of patients and shareholders.
- See more at: http://www.thechairmansblog.com/amarantus-bio...OJvKJ.dpuf
We project a partnership agreement for LymPro will follow shortly after the completion of the LP-002 study, and the Company is weighing strategic options which include a potential ‘spin-out’ of our diagnostics division (which includes LymPro and NuroPro); - See more at: http://www.thechairmansblog.com/amarantus-bio...yyooo.dpuf
This arrangement is not a classic partnership, as Amarantus is maintaining all intellectual property rights to current and future versions of LymPro at the current time. This is a services agreement that gets the ball rolling on the CLIA process as we make progress on our ongoing LP-002 clinical study and puts Icon in a sub-contractor relationship with respect to LymPro. Icon will be providing central laboratory services to Amarantus in a fee-for-service arrangement, which is their primary business model. This services agreement extends over four years and covers LymPro’s central laboratory requirements under CLIA (under CLIA, only 1 laboratory facility can run a Laboratory Developed Test), in addition to consulting support for Eltoprazine’s further clinical development and our MANF program as we move it towards human trials. With this agreement, we also gain access to a global distribution network for LymPro, including central laboratories in Europe, Singapore, India and China that will allow LymPro to enter these new markets seamlessly through an already established distribution framework .
We are continuing to evaluate shareholder value creating arrangements for our diagnostics division, including a potential ‘spin-out’ or other business arrangements that would make strategic sense for the various LymPro and Amarantus stakeholders. We will not be giving additional details related to those possible arrangements in today’s business update call, as we are contractually prohibited from doing so.
- See more at: http://www.thechairmansblog.com/amarantus-bio...csw5L.dpuf
