12-18 months from last Jan., 2014, takes us out of the parking lot and puts us on the medical billing playing field
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...last minute of Gerald's 2014 Biotech Showcase speech on Jan. 15th, 2014
http://www.media-server.com/m/p/g4dhucqq.
"....this is one of the reasons why we've chosen not to really look to partnering immediately - to explore this further,
as if with a CPT Code we believe we've dramatically increased the NPV of the (LymPro) asset...."
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Research Report Update
Meeting With Amarantus Confirms Fundamental Turnaround
01/27/2014
By Jason Napodano, CFA
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would sincerely welcome an update on this critical issue without spilling the beans to our competitors regarding CPT code designations
Quote:8.1.2 Coding
Amarantus intends to pursue the issuance of a Current Procedural Terminology (CPT) procedure code specifically for the LymPro Test. The strategy will be to initially use a miscellaneous code and negotiate directly with payers for payment of submitted claims until a specific code is issued. This process generally takes 12-18 months through the AMA and would likely result in a temporary (assuming Amarantus could show reasonable utilization data) CPT code.
______________________________________________________________________________________________________
...last minute of Gerald's 2014 Biotech Showcase speech on Jan. 15th, 2014
http://www.media-server.com/m/p/g4dhucqq.
"....this is one of the reasons why we've chosen not to really look to partnering immediately - to explore this further,
as if with a CPT Code we believe we've dramatically increased the NPV of the (LymPro) asset...."
______________________________________________________________________________________________________
Research Report Update
Meeting With Amarantus Confirms Fundamental Turnaround
01/27/2014
By Jason Napodano, CFA
Quote:"Investors previously believed that Amarantus will seek a development partner for LymPro shortly after the preparation of the analytical performance package. However, Amarantus now plans to analyze the data from the 7-year longitudinal analysis prior to forming a developmental partnership because confirmation of the impressive accurate [(sensitivity x prevalence) + (specificity x 1-prevalance)] of LymPro represents a major valuation inflection for the company. We agree. Why partner LymPro in the second quarter 2014 before this 7-year data validation, when validation means a partnership at multiples of what LymPro is worth today?
Once the data has been validated, the next step is to establish long-term analytical performance to support commercial launch in 2015 (note: management guidance is “second half of 2014”) . Amarantus expects to be in a position to submit the necessary data package to CLIA to support the intended use statement: "Aid in the diagnosis of Alzheimer's disease" and commercial launch of LymPro as a Laboratory-Developed Test (LDT) through CLIA. Following clearance under CLIA, Amarantus will focus on gaining U.S. FDA approval for 'multi-lab use'. This could occur in 2015. Once enough clinical utility data has been generated, Amarantus can approach the Center for Medicare and Medicaid Services (CMS) and gain reimbursement for broad-scale use. This is an important step, especially in light of the fact that CMS has denied reimbursement for Eli Lilly’s Amyvid given a lack of clinical and pharmaco-economic evidence.
Amarantus believes it has identified CPT Codes relating to cell cycle dysfunction and Alzheimer’s disease that might facilitate reimbursement for LymPro under CLIA or commercial sale. This would be an enormous advantage for the company, and something worth looking deeper into by management. This is yet another reason to push partnering talks out a quarter or two because progress added significant value.
The ultimate goal for Amarantus with LymPro is to gain approval as a companion diagnostic paired with a therapeutic for the treatment of Alzheimer’s disease.
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would sincerely welcome an update on this critical issue without spilling the beans to our competitors regarding CPT code designations
