I would hazard a guess the FDA would give permission as its basis is to allow the ODD drugs to be sold to pay for further research and to utilise the $2m Credit that the FDA apply in the USA to charge back for Patient Scripts .
Once permission is given ,, as this
According to Statista, Imbruvica was the top orphan drug by revenue in 2021, and Darzalex is projected to be the top orphan drug by revenue by 2028. In 2022, orphan drugs generated $156 billion in revenue worldwide
To keep @Icebluedenim happy would should take the conversation to another thread ...
The Great Pharmaust FDA ODD Approval Sweepstake, page-156
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