| How will the test eventually be commercialized in phase IV? |
| In identifying unique biomarkers, which should result in the development of a companion diagnostic, PamGene understands the importance of a drug developer’s ability to remain in control of a specific test. PamGene also expects that the biomarker work will be part of a collaborative project that runs over many years and leads to a solid relation between the companies. During phase II the biomarkers will be evaluated and in phase III the biomarkers will be used for the first time to select for responder selection in an additional arm of the trial. Finally, we have developed a business model that gives the drug development partner a choice along the road to stay with PamGene’s platform for the full commercialization phase, to make a switch to another platform building on the biomarkers discovered on the PamGene platform or to work with a third party for distribution of the companion test. |