Ok we meet this and more ! According to the FDA website, while judging whether or not a condition is serious is subjective, an easy way to identify serious conditions is if they will progressively become more severe. Beyond addressing a serious illness, applicants seeking Fast Track designation must produce a product that fills an unmet need, such as providing therapy for a condition where no treatment exists.
Despite the requirement to fill an unmet need, drugs on the Fast Track pathway may treat conditions with available therapy. However, in those cases, a Fast Track approval would require the drug or device to be
Understanding the FDA’s Expedited Approval Pathways | TechTarget