Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-85

Just to break this down. Mesoblast has caused confusion with their announcements in trying to emphasize all the "firsts" this approval would entail. They probably changed the wording this time around because people got confused in 2023 by the emphasis on children under 12.

When they say they are seeking approval in children, that is by definition up to age 18. Each announcement has always said they were seeking approval "in children."

Now, here are some of the "firsts" they have highlighted in various announcements:

If Approved, Remestemcel-L will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US,
(This means first for any condition, any age, any type of cellular medicine, not just for stem cells)

First Therapy for Children Under 12 Years Old with SR-aGVHD.
(This means for this specific condition, for children under 12, there are currently no approved therapies of any kind- or at least not at that time, in 2023?)

And from the current announcement:

First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD

(Meaning there are approved therapies for children under 18, but no cellular therapies)

It is possible there have been some approvals recently for children that has led to the changed wording? I haven't been paying attention to what is going on with those other, toxic drugs that don't reduce mortality, but folks like Wilba, Reg or Phaedrus might enlighten us on what recent approvals might have led to the new wording?