Churbz83, your moment was up 1.5 hours ago. Nothin
Post# of 30028
Posted On: 11/10/2014 8:42:07 PM
Churbz83, your moment was up 1.5 hours ago. Nothing found to support claims of the company stating there would be a BP partnership?
Here's my review of the 2014 Chairman's Blog entries for any mention of the terms pharma or partner. I find nothing mentioned that should warrant investor expectation of a BP partnership or joint venture. I believe this is a speculation discussed on the message boards in such detail that many have come to believe Gerald has stated this as a goal. Yet, it seems odd if this was a company goal, he would have mentioned it in his detailed blog posts regarding the company's strategies. I welcome others to review the press releases, corporate filings, online interviews, and conference calls for specific references to a BP partnership that would support this being an expectation for investors. Please post your findings on this board. I would welcome being proven wrong on this point, but I'm not going to do all of the work myself.
October 27, 2014:
September 18, 2014:
September 2, 2014
August 10, 2014:
August 4, 2014:
July 17, 2014:
July 9, 2014:
July 9, 2014:
June 30, 2014:
June 24, 2014: No matches.
June 18, 2014:
March 31, 2014:
March 10, 2014:
February 24, 2014:
February 3, 2014: No matches.
January 17, 2014:
January 6, 2014: No matches.
Here's my review of the 2014 Chairman's Blog entries for any mention of the terms pharma or partner. I find nothing mentioned that should warrant investor expectation of a BP partnership or joint venture. I believe this is a speculation discussed on the message boards in such detail that many have come to believe Gerald has stated this as a goal. Yet, it seems odd if this was a company goal, he would have mentioned it in his detailed blog posts regarding the company's strategies. I welcome others to review the press releases, corporate filings, online interviews, and conference calls for specific references to a BP partnership that would support this being an expectation for investors. Please post your findings on this board. I would welcome being proven wrong on this point, but I'm not going to do all of the work myself.
October 27, 2014:
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Eltoprazine is the company’s most classical asset from a pharmaceutical industry perspective. Eltoprazine was originally developed by Solvay Pharmaceuticals for the treatment of aggression in multiple psychiatric conditions.
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Combined with data emerging from our planned studies, we believe there will be significant interest from the pharmaceutical industry as our trials advance in 2015 (referring to Eltoprazine).
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We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use.
The company is currently preparing marketing materials to support the launch to both the pharmaceutical industry and the general practitioner community to ensure they understand the value that LymPro will bring to their diagnostic paradigms.
September 18, 2014:
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We entered into an agreement with Icon Central Laboratories that gives the Company access to a global distribution network for LymPro and positions us to begin marketing LymPro to the Research Use Only (RUO) in the fourth quarter – we began ‘soft marketing’ to pharma companies at the Alzheimer’s Association International Conference in July and can now definitively describe our path forward with Icon.
We have begun the assay validation work with Icon required for LymPro’s use in pharmaceutical clinical trials and expect that to be complete in the fourth quarter – LP-002 data will shape the final validation specs.
September 2, 2014
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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.
August 10, 2014:
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We intend to initiate the CLIA certification process for LymPro in the very immediate future at our prospective partner’s laboratory. The initial 12-week process is designed to prepare the analytical performance package (APP) that will be the basis of LymPro’s utility going forward.
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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)
August 4, 2014:
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To that end, we achieved our objective, as the KOL community was extremely impressed that with a single marker we were able to show a highly statistically significant differentiation between Alzheimer’s and a healthy control, and believe that collaborators in the fall will be available for the CLIA-enabling study we will be running at our prospective partner’s laboratory.
July 17, 2014:
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Many of these points were not addressed in our posters because our audience consisted of scientific teams from Big Pharma companies and Key Opinion Leaders (KOLs) who fundamentally understand the process.
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At the time, they were in discussions with several large pharmaceutical companies who were interested in the scientific concepts behind LymPro and wanted to see the data corroborated in larger studies (no PET imaging at the time to confirm diagnosis, therefore initial Version 2 studies were too small).
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This is poster #1, the analytical performance poster, presented on July 14th, 2014 and that was extremely welcome news to those in Big Pharma who had previously been aware of the LymPro program in 2008 timeframe.
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We believe this step will give us all the tools necessary to support the transition of the assay from BD into the target commercial CLIA lab partner and then restart the work PLS had conducted, and add other dementias into the cohort group (distinguishing Alzheimer’s from other dementias and cognitively intact controls using biomarkers such as Amyvid). That study will be conducted in the partner lab and will support commercial launch.
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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.
July 9, 2014:
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The data, standard operating procedures (SOPs) and other proprietary assay parameters will facilitate transfer of the assay into our prospective partner’s laboratory for the purpose of commercialization under CLIA, a process BD has executed with our target partner several times.
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Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval.
July 9, 2014:
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Targeting cell cycle is emerging as a new therapeutic target with significant potential because it is immediately attractive to drug developers who have anti-amyloid and anti-tau drugs as they may have activity within cell cycle, thereby furthering the rationale for pharmaceutical companies’ already massive investment.
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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.
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The data, standard operating procedures (SOPs) and other proprietary assay parameters will facilitate transfer of the assay into our prospective partner’s laboratory for the purpose of commercialization under CLIA, a process BD has executed with our target partner several times.
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Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval.
June 30, 2014:
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Last week we attended a successful BIO convention where we ended up participating in over 60 partnering meetings, and were extremely pleased with the reception we received from the community at large. It is clear that we have become highly visible to larger pharmaceutical companies, as well as promising early-stage companies seeking to partner their assets.
June 24, 2014: No matches.
June 18, 2014:
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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.
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We continue to make progress implementing our reimbursement strategy, which will give the Company additional leverage in potential partnership negotiations.
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At the current time, we are completing the analysis of comparing the pros and cons of a robust Phase 2b clinical trial vs. a Phase 2/3, and identifying what would make the Eltoprazine more attractive from a partnering perspective post-trial.
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We have a clear plan and strategy, and are working to establish appropriate channels for scientific, development and financial partnerships that will provide near and long-term value creation possibilities across multiple fronts.
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We believe this data will be the most compelling for Key Opinion Leaders (KOLs) and pharmaceutical companies, our target market for the initial launch of LymPro, as this will provide longitudinal data regarding LymPro’s performance and diagnostic integrity.
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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.
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We will be attending the Biotechnology Industry Organization’s annual international meeting in San Diego next week and have numerous meetings setup with large pharmaceutical companies to get a sense of how these companies will view the 2 trial design options.
March 31, 2014:
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As a result, we will be working closely with Dr. Kirby and our other advisors to prepare updated clinical development protocols and provide the most compelling data to our early customers for LymPro: pharmaceutical companies and Key Opinion Leading physicians.
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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.
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As a result of improvements in these critical areas, the Company initiated a partnering process in the first quarter of 2014 for the CLIA commercial launch of LymPro, and thereafter will evaluate the ex-US commercialization strategy.
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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.
March 10, 2014:
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We are aware that it is possible in the biotechnology industry to gain strong financial terms from potential partners eager to gain access to the Company’s technology – we can now aggressively pursue this strategy without the risk of a significant dilutive financing throughout that process;
February 24, 2014:
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Importantly, Eltoprazine has been evaluated in over 700 patients to date, and has a very strong safety profile thereby mitigating commercial safety risk for potential partners;
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The flip-side is, as was recently seen with Intercept Pharmaceuticals, that the innovation and risk small companies incur while developing their programs can be handsomely rewarded through proper preparation, diligent execution and, quite frankly, a heavy dose of luck.
February 3, 2014: No matches.
January 17, 2014:
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With the help of our advisors, we are ensuring that we build value for the program as rapidly as possible by evaluating all the necessary steps for commercialization to de-risk the asset both for Amarantus, as well as prospective partners.
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Each one of these de-risking steps, especially reimbursement, dramatically improves the net present value of LymPro which in turn would increase its attractiveness to physicians, investors and potential partners.
January 6, 2014: No matches.
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