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.
- Forums
- ASX - By Stock
- KZA
- Ann: Kazia's paxalisib granted Fast Track Designation by FDA
Ann: Kazia's paxalisib granted Fast Track Designation by FDA, page-51
-
- There are more pages in this discussion • 16 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
LU7
Discover the strong preliminary feasibility of the Bécancour Lithium Refinery, showcasing resilience in a low pricing environment and a strategic plan to capitalize on future price recoveries