Ann: Invex Granted European Orphan Drug Designation for TBI, page-47

Reon1 is incorrect unfortunately.

Priority Review Vouchers are granted to rare paediatric indications by the FDA. They are not granted for adult orphan drug indications in the US.

Also, Presendin is Invex's GLP-1 exendin formulation for IIH. Given that the ODD will be for a GLP-1, Invex will simply reformulate Exendin for TBI. This will be a new formulation and can therefore satisfy the ODD for TBI.

In other words, this is not a backup orphan drug designation. Invex can achieve orphan drug approvals for both IIH and TBI, for different GLP-1 reformulations.