Correct. Tropical Diseases is a special case for which PRV apply...

Correct. Tropical Diseases is a special case for which PRV apply for adults.

To get technical - if we're talking about Priority Review Vouchers here, then Reon1 is correct in stating that a reformulation will not get a Priority Review Voucher. This is because the active ingredient needs to be unique. Neuren's trofinetide is an example.

However, Invex is not seeking to exploit Priority Review Vouchers. It is going down a completely different pathway. It is utilising the Orphan Drug Designation pathway for which reformulation and repurposing is within scope. There is no stipulation preventing one drug from earning more than one orphan drug approval.

It is unlikely that Invex will seek to simply re-use Presendin in TBI. The active ingredient is a synthetic form of Exendin-4, for which Invex bought the rights from Astrazeneca for neurological indications. They reformulated this to 'Presendin' to match the disease characteristics of the IIH condition.

Invex will likely undergo a proof of concept study(Phase 2) for TBI, for which the final reformulation they will seek to get approval for will be different to Presendin for IIH, as they will need to use a reformulation with a different pharmacokinetic profile to be effective in TBI. We know in 2020, Invex raised capital post Phase II results, for a proof of study in a 2nd indication. Three years later, we finally know that it is for Traumatic Brain Injury, for which they're funded to complete.

Invex's strategy is simple. Achieve success in the Phase 3 for IIH. Have a pipeline of proof of concept studies in other indications e.g. TBI. And then sell to Big Pharma who will pay several multiples for the next big blockbuster drug.