Anavex Life Sciences Corp (AVXL)

[JPG77]

From Wiki:

The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.

Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.

Serious Condition: Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Unmet Medical Need: For a drug to address an unmet medical need, the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:

* Showing superior effectiveness
* Avoiding serious side effects of an available treatment
* Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
* Decreasing a clinically significant toxicity of an available treatment
* Addressing an expected public health need