Anavex Life Sciences Corp (AVXL)

[rayovacAAA]

WHAT IS DIFFERENT ABOUT APPLYING FOR RIGHT TO TRY VS. APPLYING FOR SAS APPROVAL?????????

I know we have "right to try" in the U.S., but I wish the FDA would come out like Australia to have the opportunity for anyone who is suffering to try 2-73!!

http://righttotry.org/rtt-faq/

Who qualifies for Right to Try?

To be eligible for Right to Try, a patient must meet the following conditions:

Be diagnosed with a life-threatening disease or condition;

Have exhausted approved treatment options;

Be unable to participate in a clinical trial involving the eligible investigational drug, as certified by a doctor, who is in good standing with her licensing organization and will not be compensated directly by the manufacturer for so certifying; and

Give written informed consent regarding the risks associated with taking the investigational treatment.

What drugs or treatments qualify for Right to Try?

The treatments available under the law must meet the following conditions:

Have completed an FDA-approved Phase 1 clinical trial;

Be in an active clinical trial intended to form the basis of an application for approval or be the subject of an application for approval that has been filed with the FDA; and

Be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.