Insurance In-Focus: Generex Establishes Reimbursement Plan For Oral-lyn
Apr 21, 2010 (FinancialWire via COMTEX) -- (Comment on this article at http://www.financialwire.net/2010/04/21/insurance-in-focus-generex-establishes-reimbursement-plan-for-oral-lyn/)
April 21, 2010 (FinancialWire) -- Generex Biotechnology Corp. (NASDAQ: GNBT) said it has established an action plan for obtaining cost reimbursement coverage for Generex Oral-lyn(TM), including the development of an insurance product that covers the costs of Oral-lyn(TM) and any additional and/or comparable diabetes products.
Some of the objectives in the action plan will include: the creation of a prospectus for use with Insurance Underwriters; the development of cost and risk assessment profile; identifying potential underwriters; and the creation of supporting actuarial and marketing materials.
In order to implement this program, the company has engaged the consulting services of David Brusegard, Ph.D., an individual with extensive experience in designing and marketing health related insurance and financial products.
The Generex Oral-lyn(TM) cost reimbursement plan will apply to existing and future regulatory approvals for Generex, as well as the company's United States Food and Drug Administration Expanded Access Treatment IND program.
The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.
Under the Expanded Access Treatment IND program, Generex Oral-lyn(TM) will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the company's ongoing global Phase III pivotal clinical trial of the product.
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies.
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