@irenekwshiu, as pointed out by ddwn / JDBL, I never said Ryoncil was approved only for children 12 and below. Of course not. There are now 2 approved second-line treatments for children 12 and above - Ryoncil and ruxilitinib (Jakafi), meaning the clinician (ie physician) has to choose which one to use next in cases of steroid failure.
@nosluggos it's an interesting find on the medical devices. I believe the FDA chose "under 18" for medications because that's generally the age limit for medical consent. ("Generally" because there are some nuances in the law on a state by state, indication by indication basis). Medical labels usually reflect clinical trial parameters. So, it's interesting in the case of Ryoncil that the FDA left some wiggle room at the top and did not specify an exact "pediatric" age limit. Maybe it's because of the "sibling paradox". Consider two brothers Yuri (for "younger) and Ollie (for "older"). Yuri is 16 years old and Ollie is 21. They have an acceptable HLA profile for bone marrow transplantation one to the other. Yuri develops leukemia and receives a bone marrow transplant from Ollie. If he subsequently develops aGVHD, there is no problem treating him with Ryoncil since he's clearly a "pediatric patient". But if Ollie develops leukemia and receives a transplant from his brother Yuri, and then develops aGVHD - is he a pediatric patient? One might argue that the cells causing the problem in Ollie's case are indeed the G for grafted cells of his 16 year old brother, and that he should be covered by insurance for treatment with Ryoncil, no question. In any event, I hope the company will move to do a clinical trial in adults as soon as possible. GVHD is a horrible complication that can impact bone marrow transplant patients of all ages. That includes the loved ones of each and every investor - a good reason to expand your interest beyond the narrow confines of your stock portfolio value,
@manishv.
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