Ann: Kazia's paxalisib granted Fast Track Designation by FDA, page-51

This bit makes me excited

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 outcomesAvoiding serious side effects of an available therapyImproving the diagnosis of a serious condition where early diagnosis results in an improved outcomeDecreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatmentAbility to address emerging or anticipated public health need.