Unformatted text preview: process for our product was used to estimate time and money requirements The FDA approval process model found that there is a 42% chance of obtaining a positive net present value (NPV) when 500 tests are completed in Phases 1 & 2 of Pre-FDA testing, and 1000 tests are completed in Phases 3 & 4 of Pre-FDA testing. Due to the FDA approval part of the process, this project will either be profitable or not. There is no in between area. The total capital investment for this project is $5,800,000. This accounts for manufacturing equipment, reagents, location, facilities and FDA approval costs. The total estimated time for Pre-FDA testing and FDA approval is 1.7 years. While this project has a less than 50% chance of being profitable, the theoretical design for the antibody-antigen interactions and the risk model can be adapted to different immunoassays and target diseases. This lends itself to future development of a wide variety of immunoassays....
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- Spring '10
- Chemical Engineering, Assay, Immunoassay, FDA approval