Anavex Life Sciences Corp (AVXL)

[XenaLives]

From that article:

Accelerated Approval (AA) is the only expedited program that provides a different route to marketing approval. AA approvals meet FDA standards for safety and efficacy. AA allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit. 2 A surrogate endpoint is a measurement like an x-ray or blood test that is likely to predict that the drug is working. This is in contrast to a “clinical endpoint” that measures how a person feels or functions or how long a person lives. AA is especially useful when the drug is meant to treat a disease whose disease course is long, and an extended period of time is needed to measure its effect. After a drug enters the market under AA, the drug maker is required to conduct studies to verify and describe the drug’s benefit. If such further studies fail to verify the predicted clinical benefit, FDA may withdraw approval, and has done so on prior occasions. Thus, the requirements for approval through this pathway have a key difference from traditional approvals: a post-market study to verify clinical benefit. Note that the purpose of such studies is to verify that the drug meets a clinical endpoint that shows improvement in how individuals feel, function or survive. A common misconception, for example among oncology drugs approved using surrogate survival endpoints (e.g., “progression free survival”), is that post-marketing trials must demonstrate an absolute improvement in “overall survival.” Such post-market trials are not always possible, however, and clinical benefit for such therapies can be verified based on other valid clinical endpoints.

SLEEP! GUT HEALTH!