This has been really a great ride and each milestone is so exciting. Fast tracking would be awesome. PC is usually diagnosed in late stages. Would be great to have this available to all PC patients ASAP...
Forgot this most important part?? >>> 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
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