Anavex Life Sciences Corp (AVXL)

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Cures Act. The Regulatory Explainer for the Act is located here:
http://www.raps.org/Regulatory-Focus/News/2016/11/28/26242/Regulatory-Explainer-21st-Century-Cures-Redux-and-What-it-Will-Mean-for-FDA/

It has many interesting sections that may benefit Anavex. One example is:

Sec. 3011 Qualification of Drug Development Tools
This section also follows on from FDA’s prior work from 2012 in which the agency created a new program known as the Drug Development Tools Qualification Program to qualify — i.e. validate as being useful and appropriate—new biomarkers, clinical outcome assessments, patient reported outcomes and animal models.

This section actually establishes a review pathway at FDA for such biomarkers and other development tools that can be used to help shorten drug development times, aiming to help reduce the high failure rate in drug development.

Under this section, FDA would be required to make publicly available on at least a biannual basis on its website, the following:

All drug development tools qualified, including all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product;
information on each qualification submission under the qualification process;
whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package;
formal written determinations in response to such qualification submissions;
summary reviews that document conclusions and recommendations for determinations to qualify drug development tools
- See more at: http://www.raps.org/Regulatory-Focus/News/2016/11/28/26242/Regulatory-Explainer-21st-Century-Cures-Redux-and-What-it-Will-Mean-for-FDA/#sthash.SHYTK2oM.dpuf