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Re: Talon38 post# 130311

Tuesday, 11/14/2017 7:50:19 AM

Tuesday, November 14, 2017 7:50:19 AM

Post# of 462059

25 to 26:20 min point where in response to a question he states that there will be a suite of 10 drug guidances for unmet disease needs, five of them neurological, before the end of the year. You can safely count on the 2-73 trials being structured under that guidance. Janet Woodcock with 30 years at FDA and the head of CDER and the New Drug Office, is the architect of the 21st CCA drug approval process. IMHO she is directing that all new trials conform to the modern structure under the Act. No drug trial execution will be announced until she says so and until the new guidance are published in the next weeks.



We all deal with our uncertainties each day as we must as part of the human condition. First be grateful you do no have AD or other CNS and then deal with the facts/thoughts presented by Talon and others and move on.
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