I am writing to request an opportunity for you to review information we have gathered to support an Individual, emergency use, expanded access application for Jack Fowler. I am very confident that the document we have prepared will present a very compelling case to allow access to your investigational drug SHP-609 outside of the clinical trial setting. After consultations with the FDA and some of the most experienced and powerful people throughout the pharmaceutical world, I truly believe that allowing this application to move forward to the FDA can and will work to meet the the best interests of the patient, the Hunter community as a whole, and Shire plc. We are firm in our belief that the information we have gathered to support this application enhances the clinical trial process, which in turn is a direct benefit to Shire.
If you are interested in working collaboratively to meet the needs of the entire patient community that you hope to represent, please indicate in writing if you will accept our document that lays out our position. I would very much like to receive your feedback and counter arguments against supporting this application, with hopes that we can work together to come to a resolution. Perhaps an open and honest discussion could follow as we continue to find the best way to meet the needs of this patient while supporting and enhancing the clinical trial that is currently underway.
I look forward to hearing from you with a response within the next 24 hours.