Let's put it this way...if you have an adaptive trial and submit information and receive feedback several times a month, when does the 30 day clock start?
Don't kid yourself...no matter what anyone says. Anavex has never mentioned anything other than following the currently approved FDA processes. It has and will continue to follow the current rules for Rett ph.2. even if they do some new tests or allow new never been done before endpoints...the back and forth will still be within the 90 days to respond to protocal change requests and 30 days for approval if no response from the FDA.
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