FDA orphan designation, page-3

Thanks for the link.

What is the difference / implication for IMU

Status: Designated

but

FDA Orphan Approval Status: Not FDA Approved for Orphan Indication?

Anyone knowing the difference?

	Generic Name:	Chimeric virus with a double-stranded DNA genome comprised of elements of 6 human vaccinia pox viruses with a human sodium-iodide symporter (hNIS) transgene
1	Date Designated:	09/17/2024
2	Orphan Designation:	treatment of cholangiocarcinoma
3	Orphan Designation Status:	Designated
4	FDA Orphan Approval Status:	Not FDA Approved for Orphan Indication
5	Sponsor:	Imugene Limited Suite 12.01, Level 12 4-6 Bligh Street Sydney, NSW 2000 Australia