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Re: Amatuer17 post# 135466

Thursday, 12/28/2017 8:46:31 AM

Thursday, December 28, 2017 8:46:31 AM

Post# of 462122
Past FDA CNS trial guidance has been a failure . We believed Dr. G. when he said these new guidelines were going to be changed. When???? What method/trials/examples will be used to validate the new guidance process rules? What confidence levels should we expect? Are investors supposed to continue to follow a CNS trials process that is clearly a failure or should we just buy lottery tickets instead?

We expect A2-73 to be effective and to see efforts going into V&V. Continuing to throw our investment money, time, resources and patient lives into the current FDA CNS hopper is just dumb. Precision medicine pharma trials are a step in the right direction. The FDA needs to do what it said it was going to do.

If we do not push for effective use of resources, who will?
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