These drugs will be registered as an orphan drug, it's a rare disease this guy is writing about, his sheet estimates 200 living individuals in the US. These days, many if not most drugs are registered that way. The author assumes an orphan drug registration for this drug.
The pharmaceutical company usually tries to register all their new drugs as orphan drugs initially, and as a drug becomes profitable for a certain disease, other diseases (more common diseases) are included in the registration to maximize profit.
As an addendum, the development costs for orphan drugs are not magically low, it's still multiple hundreds of millions that the company has to put up with before approval.
The pharmaceutical company usually tries to register all their new drugs as orphan drugs initially, and as a drug becomes profitable for a certain disease, other diseases (more common diseases) are included in the registration to maximize profit.
As an addendum, the development costs for orphan drugs are not magically low, it's still multiple hundreds of millions that the company has to put up with before approval.