 |
 |
The press release indicated: "He anticipates that clinical testing in humans of the lentiviral delivery system for GDNF will begin in Switzerland and the U.S. in less than five years following review in this country by the Food and Drug Administration." This is quite a promising development. I certainly hope that testing in human can proceed at an accelerated pace, much less than 5 years!! Does any one know of ways to speed up the process? I am trying to become more informed about the process. I have been a patient representative for Parkinson's at the FDA. I will attend a seminar next month at FDA on their policies and procedures. Also, I was informed by the patient representative contact at FDA that AIDS representatives have successfully lobbied drug companies to have patient representation in the design of clinical trials. I would appreciate feedback on this issue. Time is not neutral for PWP. While we do not want to compromise the safety and efficacy of new treatments, there must be a way to do it faster.