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CEL-SCI Corporation Releases Letter to Shareholders
Date:2/17/2010

an overall survival benefit.  The study will enroll about 800 patients worldwide.  

While we already showed a 33% improvement in overall survival in Phase II, we only need 10% in the Phase III study to meet our primary endpoint. We have added multiple years to the development process of Multikine in order to build a Multikine dedicated manufacturing facility near Baltimore.  This was done at the advice of the regulatory agencies and as an additional step of risk mitigation since the use of a contract manufacturer adds a great deal of risk in maintaining quality control.  We have taken every conceivable risk mitigation step to increase the probability of a favorable outcome for this breakthrough product.

On the other hand, recognizing that every drug development carries risk, we have attempted to set the study up to become a huge financial success for the shareholders.  Assuming we are right, Multikine will become the first treatment to be used in the treatment of nearly all newly diagnosed head and neck cancer patients (about 650,000 patients worldwide).  It will become part of the new standard of care.  That means that doctors will be advised to use Multikine as the first treatment for head and neck cancer patients.  Insurance companies and governments should reimburse the use of Multikine because it will be cost effective and because they pay for the current standard of care treatments, surgery, radiation and chemotherapy.  This would translate into billions of dollars in sales while at the same time helping to save lives.  Usually such successes are shared with a big pharmaceutical partner and the upside for the small company's shareholders is limited.  In the case of CEL-SCI, shareholders still control most of the upside as CEL-SCI still owns all of the major marketing rights.  Very few companies find themselves in this advantageous position a
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