Fast Track

Some will already recognise the various levels of FDA designations that allows for the accelerated approval but for our purposes lets just focus on the FDA Fast Track designation (that BTW was first introduced to combat AIDs).

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditionsand fill an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

► Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
► Avoiding serious side effects of an available therapy
► Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
► Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
► Ability to address emerging or anticipated public health need

iPPS can be given a preliminary tick for 5 of the 5 based on the Phase 2 data that is arguable more comprehensive than some P3 trials. I've highlighted last 3 categories just to bring home why I think the FDA are now surprising us with this fast track designation

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track