Anavex Life Sciences Corp (AVXL)

[Talon38]

Leo, Amateur, et, al. who are constantly commenting on the 3 trial timeframe issue. No matter what has been said about CM driving the train, that is just absolutely not so in a government regulatory process. The FDA and more exactly CDER and The OFFICE OF NEW DRUGS set the trial time progress. Fortunately, we are at the cusp of a new era in drug development and approval. That paradigm shift is being driven by Scott Gottlieb and Janet Woodcock whose ideas in this arena have been amply provided in previous posts. Scott Gottlieb is the prime advocate for safe and rapid drug approval and has achieved amazing progress in the short 6 months on the job. Listen again to his comments at the National Press club and especially at the 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.

So as I said before....give Chris, Tom. Tayo, Dan, Taso, the BOD and SAB a break and trust they have done everything possible to get the three trials underway. What is important is data not words.

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