Anavex Life Sciences Corp (AVXL)

[XenaLives]

The FDA could also approve based on P2 data, giving a path to mid to late 2017 approval.

Standards for Medical Products

While the act reduces or simplifies many regulatory obligations of manufacturers, it does not lower the standards by which medical products are introduced into the market place. In the area of drugs, the law codifies the agency's current practice of allowing in certain circumstances one clinical investigation as the basis for product approval. The act, however, does preserve the presumption that, as a general rule, two adequate and well-controlled studies are needed to prove the product's safety and effectiveness.

http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDAMA/ucm089179.htm