At 9 months old, Josh Hardy was diagnosed with a malignant rhabdoid tumor of the kidneys. It’s a highly aggressive, rare form of cancer that only 15 children are diagnosed with each year. After receiving a bone marrow transplant he developed an adenovirus, an acute infection that has left Josh near death.
Chimerix Inc holds the medicine, but is in phase three of clinical development. Chimerix Inc is unwilling to allow compassionate use as any adverse events such as organ failure, ect. could be used against them during the approval process. As Josh is near death, it is likely that these adverse events would occur anyway.
Chimerix Inc and the FDA should allow the exclusion of adverse events for special cases like Josh's where doctors confirm a patient is facing imminent death.