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polarbear77

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polarbear77

Re: Amatuer17 post# 121646

Monday, 09/25/2017 10:07:04 PM

Monday, September 25, 2017 10:07:04 PM

Post# of 463629
Amateur, have you been reading up on the new 21st CCA that was passed in Dec 2016?

Why would Anavex (or any Company) run NEW trials under the old protocols/processes/endpoints when they could/should work with the NEW 21st CCA provisions and new FDA trial guidelines after the Dec 2016 passage?

Isn't it true that the FDA has yet to release its new precision medicine master protocol trial guidelines/procedures after the 21st CCA passage?

Might you consider that this is a VERY reasonable & possible explanation for why our new trials haven't yet been p/r'd?

http://www.raps.org/Regulatory-Focus/News/2017/07/07/28050/FDA-Officials-Master-Protocols-Needed-for-Precision-Medicine/



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