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Neuralstem is a “next generation” stem cell company. Focused not on basic research on stem cells, but on how to move its Neural Stem cell technology into patients. Both our regulatory and commercial strategy is to start with indications which have smaller patient populations is the United States, and then once we have demonstrated the safety and efficacy of the cells, to branch out into larger indications. While the Company’s technology allows for the isolation and growth of cells from different regions of the Central Nervous System (CNS) our product development strategy is centered around our spinal cord cells. Neuralstem has published important, often considered breakthrough, proof of principle data with University collaborators at John’s Hopkins University and the University of California San Diego, using it’s proprietary human spinal cord derived neural stem cells. We are targeting ALS (spell out) or Lou Gehrig’s disease as it is commonly known as the first indication for therapeutic use of these cells. Pending FDA approval, we hope to start the ALS trial in the Spring of 2009. After establishing that the cells and the surgery are safe, we expect to follow the ALS trial with trials of the same spinal cord cells for Spinal Cord Injury and Ischemic induced Paraplegia. All of these indications will be eligible for orphan drug product status and/or accelerated treatment from the FDA which can extend a products exclusivity beyond the patent life and in some cases expedite the approval process. The safety and efficacy data created from these various trials will then allow us to move on to larger indications such as stroke and MS and others which share similar symptoms, possible mechanisms of action for treatment, and surgical approaches with the Spinal Cord stem cells.
The second building block of our regulatory and commercialization strategy is international product development. The demonstrated appetite for stem cell therapies is world wide. Neuralstem has established important commercial and scientific partnerships throughout Asia focused on our Spinal Cord derived stem cells and in November 2008 announced our first strategic collaboration in Germany for the development of a Huntington’s Disease therapeutic use for our cells. The Company is committed to what we envision as “near simultaneous” world wide commercialization of our technology and is actively creating the strategic relationships required. Finally, the Company is fully committed to a regulatory and commercial pathway in China, and believes that a great deal of it’s growth will take place there. The Third building block for our business plan is aggressive outsourcing. We believe that the expertise required to move the technology forward exists throughout the world, and that the Company’s money is more effiiently spent on moving programs forward in this manner, rather than spent on building expensive infrastructure. This model has allowed us to move our development forward at a rapid pace, and yet keep our overhead to a fraction of that of our main competitors. The Company is committed to a continued prudent stewardship of our resources, while creating shareholder value. |