the letter from the FDA to DNDN stinks. From my experience the FDA should be following a special protocol to approve new meds for the terminally ill. The request from DNDN is for a med for the terminally ill prostrate cancer patient, not the mainstream patient. The basic sequence for approval is a double blind phase 3 clinical, results that indicate the med is safe, results that indicate limited side effects, and results that support improved quality of life and life extension. Where did DNDN miss? I believe it did not miss and that the FDA needs alittle more clarification. Mean while, the shorts have a picnic and DNDN is approved in a few weeks or months. Yes this stinks. JMO.