Orphan Status28 Feb 2024 11:49
Since there is some chat around 'Orphan drug designation' its worth a look at what this entails.
Firstly, it is intended for rare conditions and provides protection from competition once on the market (ten years market exclusivity). So it a good thing in anyones opinion.
Secondly, its to application and designation is free and takes a maximum of 90 days from submittal.
Thirdly, companies applying for designated orphan medicines pay reduced fees for regulatory activities. This includes reduced fees for protocol assistance, marketing-authorisation applications, inspections before authorisation, applications for changes to marketing authorisations made after approval, and reduced annual fees.
We know that the board aren't drawing a salary at the moment and this process is free so not worried there.
If anything any confirmation that they have applied for Orphan status is very good news as it means the IP is secured and they will likely have a product that is protected.