FDA orphan designation for idronoxil, page-8

Hey Guys, just a moment. Are we sure this is a positive approval?

On a second read-through I noticed this line….

FDA Orphan Approval Status: Not FDA Approved for Orphan Status.

Now I would be ecstatic if the positive reading is correct …but this line above seems a touch ambiguous don’t you think?

Could it mean Not Approved ….or maybe just …Not Approved Yet?

Hmmmmm?

Apples

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	Column 1	Column 2
0	Generic Name:	Idronoxil
1	Date Designated:	03/17/2022
2	Orphan Designation:	Treatment of soft tissue sarcomas (STS)
3	Orphan Designation Status:	Designated
4	FDA Orphan Approval Status:	Not FDA Approved for Orphan Indication
5	Sponsor:	Noxopharm LimitedLevel 20, Tower A, The Zenith821 Pacific HwyChatswood, NSW 2067Australia The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.